Melody Lam

JOB DESCRIPTION Title: Global Sr. Regulatory Compliance Specialist Department: Quality Reports To: Chief Quality Officer FLSA Status: Exempt Job Summary The Senior Regulatory Compliance Specialist is responsible for ensuring that our products and technical files align with applicable regulatory requirements, including global pharmacopeias, relevant standards and testing requirements. This role supports customer inquiries, customer regulatory submissions, and monitors ongoing compliance with the standards upon which the company certifies to and will maintain and update product technical files and monitor relevant standards and pharmacopeias to ensure that upcoming changes/revisions are communicated and implemented. Essential Functions Ensure product compliance with: USP EP Other applicable global regulations/standards Monitor regulatory updates applicable to our products and assess impact on company procedures and products. Identify and support implementation of new or revised regulatory requirements. Provide recommendations for robust testing plans to ensure compliance Based on upcoming and revised regulatory changes. Review, communicate and remediate gaps in partnership with Product Line Management and Engineering for our product technical files. Perform additional job duties as assigned. Education / Certifications Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field Required Experience & Competencies Minimum 4 to 7 years of experience in pharmaceutical regulatory compliance or quality assurance. Direct experience in reviewing/interpreting USP/EP/regulatory standards and recommending/communicating implementation plans. Hands-on ownership of product technical files and regulatory documentation throughout product lifecycle. Experience monitoring regulatory updates and implementing compliance changes across product portfolios. Technical file creation and revision experience required. Strong understanding of cGMP documentation requirements. Excellent written and verbal communication skills. Travel required up to 10%

Summary We have an immediate opening for a Senior Quality Specialist. This highly visible position is responsible for meeting and exceeding goals by advancing high-quality spinal fusion solutions utilizing cutting-edge implant technology. This role supports the operations organization with day-to-day, near-term, and long-term execution of quality tasks, requiring strong interpersonal skills and the ability to quickly meet supply chain requirements while supporting customer service, sales, engineering, and operations departments. Responsibilities Route, release, and control quality system documents Assign, monitor, and retain training records Maintain supplier qualification status Support the audit program and supplier quality activities Create and manage the CAPA and complaint program Lead nonconforming material investigations and segregation activities Support Quality Management Review Conduct DMR review for incoming and outgoing inspection Support development and maintenance of quality plans Requirements Bachelor's degree 3+ years of medical device experience Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.) Ability to thrive in a startup environment Experience with an orthopedic medical device company or spine experience a plus ISO 13485 QMS auditor certificate

Summary We have an immediate opening for a Senior R&D Engineer. This highly visible position is responsible for the development and design of medical device instruments and implants, with quality and engineering development goals assigned to advance our high-quality spinal solutions using cutting-edge implant and instrument technology. This role requires strong mechanical design skills spanning brainstorming, design, prototyping support, DFM support, regulatory support, and product launch support, along with hands-on medical device design experience using SolidWorks and a solid understanding of medical device design controls. Responsibilities Lead design and development activities to release new product lines and maintain current ones Support marketing, quality, and regulatory departments as needed Mentor associate engineers and engineering interns as needed Requirements B.S. in Engineering, Mechanical or Biomechanical Minimum 5 years of related work experience (spine experience preferred) Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.) Experience with an orthopedic medical device company or spine experience a plus Ability to multi-task and thrive in a startup environment 3+ years of experience with SolidWorks design software

Director of Procurement — Medical Device Location: Irvine, California or Remote Travel: Up to 30% Summary of Role We're a scaling medical device company seeking a Director of Procurement to lead our procurement team and provide strategic oversight of all sourcing, supplier management, and contract manufacturing (CMO) operations. This is an operationally focused leadership role responsible for stabilizing and maturing our procurement processes, strengthening supplier capabilities, and building a scalable global procurement strategy aligned with our commercialization goals and compliance requirements. Responsibilities Lead, mentor, and develop a team of six buyers across direct, indirect, and NPI procurement categories Strengthen sourcing strategies for components, materials, tooling, and services Own the full supplier lifecycle — selection, qualification, onboarding, and ongoing performance management Negotiate contracts, pricing, and commercial terms to achieve cost, quality, and risk-mitigation goals Serve as the primary operational interface for external manufacturing partners in Germany and other global regions Oversee capacity planning, production scheduling, and issue resolution with CMOs Support technology transfer, scale-up, and validation activities in collaboration with Engineering and Quality Establish and maintain supplier governance frameworks, KPIs, and performance review mechanisms Ensure supplier compliance with ISO 13485, EU MDR, FDA QSR, and internal quality requirements Lead supplier audits, corrective actions, and risk-mitigation initiatives Maintain supplier risk assessments and business continuity plans Partner cross-functionally with Engineering, Quality, Regulatory, and Finance to align procurement strategy with product development and commercialization milestones Support ERP, MRP, and master data initiatives related to suppliers, materials, and BOM accuracy Deliver regular reporting on procurement KPIs, supplier health, cost performance, and risk exposure Participate in and contribute to S&OP and broader company strategic goals Requirements Bachelor's degree in Supply Chain, Engineering, Business, or a related field 6–10 years of procurement and supplier management experience in MedTech, preferably with Class III Cardiovascular or Neurovascular experience Demonstrated experience managing CMOs and leading cross-functional sourcing initiatives Working knowledge of EU MDR, ISO 13485, and FDA QSR regulations Experience working in a startup or high-growth environment preferred Strong negotiation capabilities with a track record of managing complex supplier relationships preferred Proficiency with ERP systems, procurement tools, and data-driven decision-making preferred

Location: San Diego, CA (On-site) Summary We're seeking a Staff Engineer to serve as the primary technical owner of our next-generation medical device platform's electronics and firmware system — spanning board-level hardware, embedded firmware, and system integration. This is a hands-on, individual-contributor technical ownership role (not people management), where you'll be the central technical point of contact for our external electronics and firmware development partners, taking boards from design through bring-up, integration, and verification. Responsibilities Serve as the primary technical point of contact for external electronics and firmware development partners, reviewing and approving their schematics, PCB layouts, and firmware architecture Own board-level architecture decisions, board bring-up, debug, and validation using lab equipment (oscilloscopes, logic analyzers, multimeters) Own firmware and software architecture and technical roadmap, including driver, RTOS, connectivity, and UI integration work Own system integration end-to-end, diagnosing and resolving issues spanning the hardware/firmware boundary Define and track system-level integration and verification test plans with Quality Keep development activities aligned with Design Controls, IEC 62304, and IEC 60601 requirements Support technical investigations for field issues, NCRs, and CAPAs Requirements Bachelor's degree in Electrical Engineering, Computer Engineering, or related discipline (or equivalent practical experience) 8+ years of combined hardware and embedded firmware experience Demonstrated experience managing or coordinating the technical work of external development/contract engineering partners Strong embedded C experience, including RTOS (e.g., FreeRTOS) and MCU peripheral configuration (GPIO, ADC, timers, PWM, UART, SPI, I²C, DMA, interrupts) Experience with STM32 or comparable MCU platforms Proven ability to bring up, debug, and troubleshoot circuit boards using standard lab equipment Ability to read and review schematics and PCB layouts Medical device or other regulated product experience preferred Key Requirements Summary 8+ years combined hardware + embedded firmware experience Strong embedded C, RTOS (FreeRTOS), STM32/MCU peripheral work Board-level hardware: schematic/PCB review, bring-up, debug with lab equipment Experience managing external design firms/contract engineering partners Medical device/regulated industry experience strongly preferred (IEC 62304, IEC 60601)

Manufacturing Engineering Manager | Irvine, CA (Onsite) You'll lead and manage precision CNC machining and assembly operations while driving cost reduction, process improvement, and the transfer of new product development into full production. Responsibilities: Provide people leadership and technical direction to a team of 9 across Manufacturing Engineers and Machinists Oversee precision CNC machining operations, including manual machine shop equipment and assembly line processes Lead NPD-to-production transfer, taking new products through first-time production launch Drive cost reduction and process improvement initiatives across manufacturing operations Manage day-to-day priorities, mentorship, and performance across the manufacturing engineering team Partner cross-functionally with Quality, Engineering, and Operations to resolve production and process issues Support production readiness and scalability across machine shop and assembly line environments Required Experience: B.S. Degree or higher with 7+ years of relevant experience in Manufacturing Engineering 4+ years of people-management experience Strong background in precision CNC machining Experience in a regulated manufacturing environment; medical device experience preferred Proven people management experience — this role carries more direct leadership responsibility than a typical IC-level engineering role Hands-on oversight experience across both machine shop and assembly line operations Direct experience leading cost reduction and process improvement projects Track record of transferring new product designs into production for the first time Logistics Fully onsite in Irvine, CA Salary: $165K–$175K

R&D Manager — Orthopedic Summary We're looking for an R&D Manager to lead the design and development of orthopedic and powered surgical medical devices, from concept through commercialization. You'll provide technical, functional, and people leadership to an engineering team, driving cross-functional product development with Manufacturing, Quality, Regulatory, Supply Chain, and Business Development. This role ensures compliance with design controls, manufacturability, and regulatory requirements while optimizing product performance, reliability, cost, and scalability. The ideal candidate has hands-on experience developing powered electromechanical surgical devices — surgical handpieces, drills, drivers, reamers, saws, robotic end effectors, or similar orthopedic instrumentation — along with a proven track record leading engineering teams and bringing medical devices to market in a regulated environment. Responsibilities Lead design and development activities from customer requirements through proof of concept, verification/validation, and commercialization Provide technical leadership and direction to engineers and designers, including mentoring, work prioritization, and performance guidance Own product development programs, including timelines, deliverables, and cross-functional alignment with Manufacturing, QA/RA, Supply Chain, and Business Development Ensure compliance with design control requirements, including Design History Files (DHF) and Technical Files; review and approve engineering designs, drawings, specifications, and test protocols Drive Design for Manufacturability, Inspection, and Assembly (DFMIA) to support efficient, scalable production Evaluate and resolve complex design and process issues impacting product performance, manufacturing, inspection, or assembly Lead tolerance analysis, risk assessments, and design reviews Collaborate with internal teams and external suppliers to support development, troubleshoot issues, and optimize designs Oversee verification and validation activities, including test method, protocol, and report development Gather and analyze data related to manufacturing processes, costs, materials, and methods to support decision-making Participate in or lead customer interactions related to product development initiatives Lead or participate in continuous improvement initiatives related to engineering processes and product development Requirements Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related field required; advanced engineering degree a plus 7+ years of relevant industry experience in product design and development (5-10 years as a Design Engineer within medical devices) Prior leadership or supervisory experience strongly preferred Experience in regulated industries required, preferably medical device, with working knowledge of IEC 60601-x, ISO 13485, and FDA 21 CFR Part 820 Strong experience with design controls and DHF requirements; ISO 14971 risk management experience preferred Proficiency in 3D CAD software (SolidWorks preferred) Strong background in electromechanical product design and development; CNC machining and manufacturing process experience preferred Strong understanding of Design for Manufacturability, Inspection, and Assembly (DFMIA) Advanced knowledge of ASME Y14.5 GD&T and engineering drawing standards; ability to perform tolerance stack-up analysis Strong analytical and problem-solving skills with a data-driven approach

We're looking for a Director of Clinical Research to own our clinical research organization — the data collection and scientific backbone of the company. You'll lead a team of 10+ research associates, data scientists, and data engineers, and serve as the senior physiological authority across every human research study powering our hardware, sensing, and AI/ML teams. You'll also own program management across the clinical team's full breadth — hardware studies, AI/ML development studies, and women's sleep studies — while acting as our public-facing voice on the science of sleep, from peer-reviewed publications to press and podcast appearances. This is a hands-on leadership role: you'll be as comfortable defining statistical criteria and reviewing raw data as you are managing people, budgets, and cross-functional stakeholders. What You'll Do Own the clinical research & science organization — lead, mentor, and grow a team of 10+ spanning clinical operations, data engineering, and data science Direct all human research studies supporting Hardware, Sensing, and AI/ML teams, from protocol development and study ideation through IRB submission, data collection, analysis, and reporting Uphold scientific validation standards by applying rigorous statistical and testing criteria (e.g., MAE, TOST equivalence testing, Bland-Altman analysis) to evaluate hardware and algorithm performance before launch Translate research into product features by partnering with Product, Growth, Design, and Engineering teams on science-backed features Provide scientific input on marketing claims, press releases, and journalist articles, ensuring every public-facing claim is backed by data Lead scientific communications — author and direct blog posts, white papers, and peer-reviewed publications, and represent the company in press interviews, podcasts, and conference talks Manage team growth and performance, including hiring, compensation strategy, mentorship, and formal performance management Drive new research exploration, identifying and pursuing external collaborations and new areas of sleep science Own budget and vendor management for clinical studies What You Bring PhD in physiology, neuroscience, sleep science, or a related field 10+ years of human research experience, including at least 5 years at high-growth startups or consumer health/hardware technology companies 5+ years of people management experience, including hiring, compensation decisions, and formal performance management Experience with biosensing devices or consumer health technology pursuing clinical validation Strong record of peer-reviewed publications; experience as author or Principal Investigator on IRB-approved clinical studies Advanced statistical fluency — able to define statistical criteria, run power calculations, and work directly with raw data alongside data scientists and biostatisticians Experience managing cross-functional programs spanning hardware validation, sensing, AI/ML, product, and marketing Excellent written and verbal communication skills across scientific and consumer audiences Hands-on, execution-oriented mindset, comfortable owning studies end-to-end in a fast-moving environment

Principal Optical Engineer | San Diego, CA (Onsite) We're hiring a Principal Optical Engineer to own the optical architecture of a next-generation DNA sequencing platform — from concept through commercialization. You'll drive the design, simulation, tolerancing, and characterization of a high-sensitivity optical detection system, partnering closely with cross-functional and external CRO/CDMO teams to bring a manufacturable product to market. What You'll Do Define optical architecture and technical strategy for high-throughput DNA sequencing platforms Lead end-to-end design, modeling, and optimization of illumination, imaging, and detection paths Perform optical design, ray tracing, tolerance analysis, and stray-light analysis in Zemax OpticStudio Build, align, test, and characterize optical prototypes and subsystems on the bench Define specs for custom optical components, coatings, and sources; own supplier drawings and acceptance criteria Partner with manufacturing contractors to transfer designs from prototype to volume production Lead the optical system through feasibility, design verification, design transfer, and commercial launch Collaborate with mechanical, electrical, software, and assay teams for full instrument integration What You Bring M.S. or Ph.D. in Optical Engineering, Optical Sciences, Physics, Electrical Engineering, or related field 10+ years of optical engineering/system design experience with multiple products commercialized Expert-level Zemax OpticStudio (sequential and non-sequential modeling, optimization, tolerancing) Hands-on bench experience with optical alignment, testing, and characterization Experience working with CRO/CDMOs and contract manufacturers on make-vs-buy and design transfer Deep knowledge of aberrations, diffraction, radiometry, polarization, and detector/sensor selection Preferred: experience with ultra-high-sensitivity detection (fluorescence, single-molecule, low-light imaging) and life science/genomics/diagnostics instruments Compensation & Benefits $175,000–$210,000/year (DOE) Medical, dental, vision; company-paid life insurance; 401(k); generous PTO

Principal Supplier Quality Engineer | Fremont, CA (Onsite 3x/week with up to 50% travel to South Bay) We're looking for a Principal Supplier Quality Engineer to build our supplier quality management program from the ground up. This is a brand-new role — you'll be the dedicated supplier quality authority, owning the full lifecycle of supplier qualification, auditing, monitoring, and performance management for a fast-growing medical device company. You'll wear multiple hats, partner cross-functionally, and have real influence in shaping how we manage suppliers as we scale. What You'll Do Design, implement, and continuously improve our Supplier Quality Management Program — supplier qualification, controls, auditing, monitoring, and risk management Lead qualification and oversight of contract manufacturers, sterilization providers, and critical suppliers Plan, conduct, and report on supplier audits and assessments Own SCAR management from initiation through effectiveness verification Investigate supplier quality issues, drive root cause analysis and corrective action Build and maintain supplier scorecards, risk profiles, and performance metrics Partner cross-functionally with Engineering, Operations, Manufacturing, Supply Chain, and Regulatory Affairs Support FDA inspections, notified body audits, and customer audits Apply risk-based decision-making per ISO 14971 What You Bring 8-10+ years of Quality Assurance / Supplier Quality experience in the medical device industry Strong working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 Proven experience qualifying, auditing, and managing suppliers, including SCAR management Background in medical robotics, orthopedic implants, capital equipment, or electromechanical devices strongly preferred but not required Experience building a supplier quality program from scratch a big plus ASQ CQE, CSQP, CQA, or ISO 13485 Lead Auditor certification preferred Comfortable with up to 50% travel to our primary supplier located in South Bay Logistics Onsite 3 days/week when not traveling to South Bay Supplier Full medical, dental, and vision; KPI-based bonus; stock options Please note: this role is not eligible for visa sponsorship, including TN visas

Position Overview Lead Quality Operations and the Quality Management System (QMS) for a San Diego manufacturing site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership across Quality Assurance and Quality Control, drives continuous improvement and risk management, and partners closely with site leadership to strengthen product quality, operational performance, and customer satisfaction. Reports to the Quality Director and works cross-functionally with Operations, Production, Engineering, Customer Service, and Sales. Responsibilities 🔹 Own the QMS and Quality Operations, ensuring compliance with regulatory, customer, and business requirements 🔹 Provide leadership, coaching, talent development, and performance management for QA/QC teams 🔹 Develop and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality 🔹 Establish quality objectives and KPIs aligned with business goals 🔹 Lead quality risk management across products, processes, suppliers, and quality systems throughout the product lifecycle 🔹 Ensure effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls 🔹 Lead Management Reviews and report quality performance, compliance, risks, and improvement initiatives to executive leadership 🔹 Direct internal, supplier, customer, certification, and regulatory audit programs, ensuring timely closure of findings 🔹 Ensure audit readiness and lead Quality representation during inspections 🔹 Establish and maintain a supplier quality management program, including qualification, monitoring, audits, and performance reviews 🔹 Promote a prevention-based quality culture through training, risk management, and continuous improvement initiatives Requirements ✅ Bachelor's degree in Engineering, Manufacturing, Quality, or a related field ✅ 5–7 years of experience in Engineering and/or Quality, preferably in medical device ✅ 3+ years in a supervisory or management role ✅ Experience with quality risk management principles in a regulated manufacturing environment ✅ Expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes ✅ Track record leading teams and driving continuous improvement in quality, compliance, and business performance ✅ Proficient in MS 365 applications ✅ Experience with ERP/MRP systems, electronic QMS (eQMS), and data analytics/reporting tools ✅ Comfortable working in both office and manufacturing environments, including occasional lifting up to 25 lbs

Own the technical launch of a brand-new medical device production line, from first specs through full qualification and ramp-up. This is a hands-on, high-visibility role for someone who wants to be the go-to technical owner for a line — not just a contributor to one. Responsibilities: 🔹 Line specs, layout, capacity, cycle time, and staffing to meet business needs 🔹 Production builds — component availability, design configurations, special builds 🔹 Key production metrics: yield, scrap, throughput, cycle time, OEE, uptime, process capability 🔹 Design transfer from R&D into operations — bridging development through qualification and launch 🔹 Equipment procurement, installation, commissioning, and ramp-up 🔹 PFMEAs, control plans, process risk assessments, and validation protocols (IQ/OQ/PQ) 🔹 Continuous improvement, capacity expansion, and cost-reduction initiatives Required Experience: ✅ Bachelor's in Mechanical, Manufacturing, Biomedical, Industrial, or Electrical Engineering ✅ 5+ years in manufacturing or process engineering ✅ Direct experience standing up and managing a new production line for a medical device — not just operating an already-mature line ✅Strong grasp of line design efficiency and line balancing (identifying bottleneck/slowest equipment, determining trade-offs on equipment speed) ✅ Hands-on with equipment specification, installation, commissioning, and process validation ✅ Strong grasp of DOE, SPC, process capability, and root-cause analysis ✅ Comfortable owning cross-functional communication across Manufacturing, Quality, R&D, Ops, and Supply Chain ✅ Medical device or other regulated manufacturing background ✅ ISO 13485, process validation, and manufacturing risk management knowledge ✅ Experience with automated assembly, dispensing, bonding, inspection, packaging, or test equipment ✅ Lean/Six Sigma, OEE, PFMEA, and control plan experience 📍 On-site in Irvine, CA — regular cleanroom work, with frequent commute to San Diego for business meetings

Senior Android Software Engineer — San Diego (On-site, Medical Device) A growing medical device company is looking for a Senior Android Engineer to join a small, tight-knit mobile team building software that's an integral part of a connected medical device ecosystem. This is a high-impact role at the intersection of mobile software, connected hardware, and patient care. What makes this role different: 🔹 100% native Android development in Kotlin — no cross-platform frameworks 🔹 You'll own complex features end-to-end — design through implementation, verification, release, and post-market support 🔹 Work directly with embedded, cloud, systems, cybersecurity, and regulatory teams 🔹 BLE and connected-hardware experience is a big plus 🔹 Open to Sr. SWE or Technical Lead level, depending on background — room to grow into a leadership track What they're looking for: ✅ 7+ years professional software development, strong Android focus ✅ Advanced Kotlin, Jetpack Compose, Coroutines/Flow, modern Android architecture ✅ Experience building apps that run reliably in the background — handling connectivity drops, OS restrictions, device restarts ✅ A genuine Android enthusiast — someone who's plugged into the platform and excited by new OS releases ✅ You've personally shipped an app to the Play Store ✅ Medical device, digital health, or other highly regulated industry background (DoD, etc. also considered) ✅ Strong ownership mentality — you build it right the first time Details: 📍 San Diego, CA — on-site, hybrid Tues–Thurs in office 💰 Competitive base + RSUs + bonus 🚫 No visa sponsorship available

Director of Clinical Affairs Can be based in San Francisco, CA or Boston, MA We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense role for someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-market surveillance — not just a single phase of the lifecycle. What You'll Do Own the full device/SaMD clinical lifecycle — from early-stage study design through trial execution, final study report, and post-market surveillance Develop study design from scratch in close collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees Lead clinical study execution — feasibility, site selection, activation, enrollment, monitoring, and close-out Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents Select, qualify, and oversee third-party clinical sites and investigators as primary point of contact Manage clinical data operations — eCRF design, data review, query resolution, vendor coordination Develop study timelines, budgets, and risk mitigation plans, reporting clearly to leadership Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight Collaborate cross-functionally with regulatory, product, engineering, and legal teams Support RA/QA peers on FDA interactions, pre-subs, and 510(k) submissions Build and scale the clinical operations function — SOPs, templates, and tracking systems Maintain post-market surveillance activities, including adverse event monitoring and reporting What You Bring Minimum B.S. Degree with 10+ years hands-on clinical operations experience (5+ in leadership) running trials for FDA-regulated medical devices, SaMD/digital health, or combination products Demonstrated experience owning a device or SaMD through the complete lifecycle — from initial concept and study design through trial completion and post-market surveillance Track record of building study designs from scratch alongside key internal and external stakeholders Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation Familiarity with RWE study designs and decentralized/hybrid trial models Startup or scale-up experience building processes from scratch Experience supporting breakthrough device designations or pre-sub meetings Experience launching studies across multiple regions/countries, with direct exposure to varying regulatory bodies and government requirements Track record of trials leading to FDA clearances/approvals or labeling expansions Experience managing third-party clinical sites end-to-end (selection through close-out) Proven ability authoring IRB/Ethics submissions, ICFs, and clinical protocols 7+ years cross-functional program management across clinical, engineering, and regulatory Strong clinical data management knowledge (eCRF, data cleaning, query management, database lock) Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH-GCP, ISO 14155, and SaMD guidance Experience with study budgeting, vendor management, and CRO oversight KOL relationship-building experience

🚀 We're Hiring: Director of Medical Operations — San Francisco An innovative consumer health technology company is looking for a Director of Medical Operations to lead manufacturing operations and design verification/validation for their medical products division — working closely with R&D, Clinical, QA/RA, and the executive team. What you'll own: 🔹 Manufacturing controls and process implementation specific to medical-grade products — while maintaining operational velocity 🔹 Global (OUS) manufacturing oversight — hands-on partnership with international manufacturing partners across varying quality maturity levels 🔹 Design verification and validation testing efforts, in close collaboration with R&D and QA/RA 🔹 Risk management documentation guidance across cross-functional engineering teams 🔹 Bridging QA/RA and Engineering to accelerate medical product upgrades from the consumer platform What you bring: ✅ 8+ years in operations or manufacturing for medical devices, ideally with a background spanning both medical-grade and consumer product environments ✅ Track record supporting successful FDA clearances (510(k), De Novo) ✅ Experience managing and initiating global manufacturing initiatives (Asia, Mexico, etc.) — comfortable being hands-on when something breaks and needs a boots-on-the-ground fix ✅ Strong cross-functional program management across Engineering, QA/RA, and Manufacturing ✅ Bachelor's degree or equivalent experience

Director of Software (San Diego, CA — On-site) An innovative medical device company at a growth inflection point — with a product already in clinical studies — is seeking a Director of Software to lead and scale their software organization. This is a builder's leadership role reporting to the VP of R&D, combining hands-on technical depth with people leadership as the team grows from lean and high-performing into full commercial scale. What you'll own: Build and scale the software team — hiring, mentoring, and establishing a culture where engineers do their best work Drive engineering effectiveness — coding standards, workflows, and AI-enabled acceleration Translate executive vision into actionable technical strategy and roadmaps Stay technically hands-on — prototype, review, and build alongside the team Represent software cross-functionally with hardware, data science, regulatory, and executive stakeholders Own team budget, resource allocation, and delivery timelines What we're looking for: Bachelor's degree in Computer Science, Software Engineering, or related field 10–15+ years in software development, including 5+ years managing technical teams Experience shipping mobile apps and cloud backends end-to-end, ideally for a connected-device fleet Regulated industry experience — medical device or other safety-critical software strongly preferred Fluency in modern DevOps, CI/CD, and automation testing Comfort applying AI tools safely and effectively within a regulated environment 📍 Must be local to or willing to relocate immediately to San Diego, CA — this is an on-site role.

Senior Director, Regulatory Affairs Summary Our client is a well-funded, growth-stage medical technology company developing a Class III active implantable platform at the intersection of healthcare and advanced engineering. This role serves as the senior regulatory leader for the company's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. The Senior Director will own regulatory strategy for new platform development, oversee ongoing product updates and manufacturing-related submissions, and work closely with engineering, quality, and clinical teams to ensure regulatory readiness throughout the product lifecycle. Responsibilities Lead regulatory strategy and submission planning for software, firmware, and hardware across new product development programs and product updates Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed Develop and execute software and firmware regulatory strategy for complex implantable devices, including AI/ML considerations, change management, and lifecycle documentation Provide regulatory support for manufacturing-related activities, including process changes and design transfers Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization Provide regulatory guidance on new product concepts, design inputs, and technology transfers Support project planning and roadmaps with well-defined regulatory milestones and risk assessments Monitor evolving FDA regulations, guidance, and international standards relevant to Class III implantable devices and complex software/firmware-driven medical technologies Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations Represent the company in FDA meetings, pre-submission interactions, and agency correspondence Minimal travel expected ( Requirements Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred 12+ years of regulatory affairs experience in the medical device industry, including demonstrated experience with complex Class II or III Medical Devices. Strong software and firmware regulatory expertise, including AI/ML-enabled features and applicable FDA guidance Track record of independently leading FDA submissions (IDE, PMA, supplements) and managing agency interactions Familiarity with manufacturing-related regulatory considerations (process changes, design transfers) in a device development or scale-up context Experience supporting new product development from concept through submission, including design control and risk management Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards Exceptional written and verbal communication skills; able to translate regulatory complexity for engineering and executive audiences Comfortable operating in a lean, startup-style environment Preferred : RAC certification (RAPS); experience with implantable neurotechnology or neural stimulation devices; familiarity with OUS pathways (CE Mark, TGA); experience scaling a regulatory function at a growth-stage company.

No C2C or Visa Sponsorship Available Staff Quality Engineer 📍 San Diego, CA — Onsite BioTalent is hiring a Staff Quality Engineer for a medical device company in San Diego to own and continuously improve their Quality Management System across the full product lifecycle. This is a hands-on, high-ownership role reporting directly to the VP. Responsibilities: Coordinate and maintain QMS processes and documentation across the organization Lead the design control program in partnership with R&D, clinical, and operations Represent Quality within the change control system — reviewing and approving changes Lead CAPA activities including root cause analysis, problem definition, and effectiveness checks Support NMR and complaint handling, supplier qualification, and incoming inspection Lead the internal audit program and support external audit and inspection readiness Requirements: B.S. in a technical discipline 8-10+ years in a quality role within a medical device manufacturing environment 3+ years of quality system auditing experience Strong command of ISO quality systems and harmonized standards for medical devices Hands-on execution experience Nice to have: Software-enabled/connected device experience, FDA inspection support, MDR/CE marking, diabetes clinical space background

Product Manager (Senior Staff/Associate Director Level) Hybrid on-site in San Diego, CA About the Role A San Diego-based biotech developing next-generation genomics platforms to transform genetic testing and sequencing is hiring a Product Manager to own the product strategy and commercialization of their target detection platform. This is a hybrid product-and-marketing role: you will translate customer and clinical insight into product requirements and roadmap, build the business case and competitive positioning, and drive go-to-market strategy, launch, and post-launch performance — partnering with engineering, assay, regulatory, and software teams across RUO, LDT, and IVD development phases. Key Responsibilities Own product strategy and roadmap for the company's target detection platform, translating VOC from clinicians, lab directors, and KOLs into prioritized product requirements Partner with engineering, assay development, integration, software, regulatory, and operations to balance clinical value, technical feasibility, and time-to-market Develop product positioning, messaging, and value propositions for clinical, laboratory, and economic buyers — including health-economic and clinical-utility narratives Build business cases and financial models (market sizing, segmentation, ROI) to support executive go/no-go decisions Conduct competitive analysis across sepsis, pathogen identification, and AMR detection to identify differentiation and white-space opportunities Drive GTM strategy with commercial, sales, and marketing leadership — including pricing, channel, and launch-readiness planning Lead product launches end-to-end: sales enablement, collateral, training, KOL engagement, adoption tracking, and post-launch performance Collaborate with regulatory and quality teams to ensure product requirements and commercial materials are compliant in a regulated diagnostics environment Define and track product and commercial success metrics to inform roadmap prioritization Required Qualifications Bachelor's degree in life sciences, biomedical engineering, business, or a related discipline with 8+ years of relevant PM and/or product marketing experience in diagnostics or life sciences. MBA or advanced degree preferred. Demonstrated PM and/or product marketing experience in diagnostics, life sciences, or medical devices — with a track record of bringing products from concept through commercialization Hands-on IVD and LDT development experience, including familiarity with the requirements they impose on product and commercial activities Proven ability to translate VOC and clinical insight into prioritized, actionable product requirements Track record building business cases, financial models, and competitive analyses to inform executive decision-making Experience defining and executing GTM strategy, including positioning, messaging, and value proposition development Strong cross-functional leadership and communication skills across R&D, regulatory, clinical, commercial, and executive stakeholders Self-directed and ownership-oriented — comfortable operating with significant autonomy in an early-stage, evolving environment Preferred Qualifications Direct experience in molecular diagnostics, ideally in sepsis and/or pathogen identification Familiarity with clinical microbiology and infectious disease testing landscapes, workflows, and buyer dynamics Experience developing clinical-utility content, health-economic/ROI models, and KOL and clinical-evidence strategy Experience at an early-stage or scaling diagnostics company balancing near-term delivery against long-term platform strategy Why Join Us Work on cutting-edge genomics and molecular detection technologies Shape the commercial strategy of a differentiated diagnostic platform from the ground up Collaborate with a deeply technical, cross-functional team High visibility and direct impact on product, commercial, and strategic decisions at an early stage

Job Title: Senior Biomedical Engineer Works closely with and have impact on: Global Quality, Global Regulatory, Operations Reports to: Director of Biomedical Research Function: Research & Development Work Location/Site: Irvine, CA Role Overview The Senior Biomedical Engineer is a subject matter expert for biocompatibility of ophthalmic medical devices, with a primary focus on intraocular lenses (IOLs). This role requires in-depth expertise in ISO 11979-5 and the ISO 10993 series, combined with a strong background in materials science, analytical chemistry, and chemistry-based testing. The individual will function as a contributor, providing scientific leadership to support product development, regulatory compliance, and biocompatibility related activities. Duties and Responsibilities Serve as the biocompatibility subject matter expert for intraocular lenses (IOLs) and associated delivery systems. Develop and execute biological evaluation strategies in accordance with ISO 10993-1, ISO 11979-5, and related standards. Design, review, and interpret analytical and chemistry-based testing data (e.g., GC-MS, HPLC, LC-UV) and translate results into regulatory-relevant conclusions. Manage and technically oversee external CROs, including protocol review, study oversight, and report review. Perform biological evaluations, risk assessments, safety risk impact assessments (SRIAs), and gap assessments to identify testing needs, scientific rationales, and risk mitigations. Collaborate cross-functionally with R&D, Regulatory Affairs, Quality, Manufacturing, and Supplier Quality teams. Write and review detailed technical reports to support global biocompatibility related matters ensuring scientific rigor, clarity, and compliance with regulatory standards and internal quality systems. Requirements Experience Minimum of 5–7 years of experience in biomedical research, medical device biocompatibility, or related fields. Direct experience supporting biocompatibility assessments for implantable medical devices, preferably ophthalmic devices. Hands-on experience with analytical and chemistry-based testing in support of biocompatibility (e.g., E&L, material characterization). Experience authoring protocols, technical reports, and regulatory-facing documentation. Skills/Accreditations Expert-level proficiency in ISO 11979-5 and ISO 10993 series standards. Strong background in materials science, polymer chemistry, and analytical sciences. Experience with analytical techniques such as GC-MS, HPLC, LC-UV, ICP-MS, etc. Excellent technical writing and report authoring skills. Strong risk assessment, critical thinking, and problem-solving abilities. Excellent communication and cross-functional collaboration skills. Academic Qualifications Master's degree or PhD in Materials Science, Biomedical Engineering, Chemistry, Analytical Sciences, or a closely related field. Advanced academic training with a strong emphasis on chemistry and analytical techniques is required. Travel Requirements None

We’re partnering with a high-growth, global life sciences manufacturer at the forefront of bioprocessing and single-use technologies . They’re hiring a Quality Engineer to drive quality performance across complex, GMP manufacturing operations supporting leading biopharma customers. The Role Lead quality investigations (complaints, non-conformances, sterility issues) Own root cause analysis + CAPA delivery Partner cross-functionally across Manufacturing, Engineering, R&D, and Supply Chain Drive continuous improvement (Lean / Six Sigma / SPC) Act as key interface for customer, supplier, and regulatory quality topics Support GMP, cleanroom, and validation-driven manufacturing processes What They Need Experience in biotech / pharma / medtech manufacturing environments Strong grounding in QMS (CAPA, change control, deviations, validation) Exposure to GMP and ISO (9001 / 13485 / FDA) Proven ability to solve complex manufacturing quality issues Comfortable operating in a fast-paced, cross-functional environment Why This Role High-impact role supporting cutting-edge biopharma manufacturing Exposure to complex, high-value products and global customers Opportunity to drive real operational and quality improvements at scale

We’re partnering with a high-growth, global life sciences manufacturer at the forefront of single-use bioprocessing technologies . They’re hiring an NPI Quality Engineer to sit at the intersection of R&D, Manufacturing, and Quality , ensuring new products are designed, validated, and successfully launched into GMP production. The Role Act as Quality lead across New Product Introduction (NPI) programmes Drive design controls, risk management (DFMEA / PFMEA), and validation activities (IQ/OQ/PQ) Ensure manufacturing readiness for product launch (builds, documentation, transfer) Support sterilisation validation (EO, Gamma, E-beam) for single-use products Partner cross-functionally to deliver robust, scalable manufacturing processes Contribute to CAPA, change control, and continuous improvement What They Need Experience in biotech / pharma / medtech manufacturing quality Strong knowledge of ISO 13485 / 9001, GMP, and design controls Hands-on experience with validation, risk management, and product transfer Exposure to cleanroom manufacturing and sterile products Ability to operate across cross-functional product development teams Why This Role Direct impact on bringing new products to market Work at the cutting edge of bioprocessing and single-use technologies Opportunity to influence product quality from design through to scale

e’re partnering with a high-growth, global life sciences manufacturer scaling rapidly across complex, regulated supply chains . They’re hiring a Supplier Quality Engineer to own supplier performance, drive compliance, and ensure externally sourced materials meet the highest quality and regulatory standards. The Role Lead supplier qualification, audits, and onboarding Own supplier performance (KPIs, scorecards, continuous improvement) Drive SCARs, root cause analysis, and CAPA effectiveness Support supplier-related validation and change control activities Partner cross-functionally across Supply Chain, Engineering, and Manufacturing Ensure compliance with FDA, ISO 13485, and global regulatory standards What They Need Experience in medical device / biopharma quality environments Strong knowledge of supplier quality, audits, CAPA, and risk management Proven ability to manage supplier performance and drive improvement Confident operating in regulated, multi-site supply chains Ability to lead audits and influence both internal and external stakeholders Why This Role High-impact role across a global supplier network Direct influence on product quality and regulatory compliance Opportunity to shape and elevate supplier quality strategy at scale

We’re partnering with a rapidly scaling, global life sciences manufacturer investing heavily in quality, compliance, and operational excellence . They’re hiring a Director, Quality Operations to lead and evolve site-wide quality systems, drive performance, and build a best-in-class quality function. The Role Own and optimise the site Quality Management System (ISO 9001 / 13485 / cGMP) Lead CAPA, non-conformance, audit, and inspection frameworks Oversee high-risk investigations and product quality decisions Drive continuous improvement across quality operations Lead, mentor, and scale a high-performing quality team Partner cross-functionally to ensure quality at scale across products and regions What They Need Proven leadership in pharma, biotech, or medical device manufacturing Deep expertise in QMS, audits, CAPA, and regulatory compliance Strong track record of driving quality transformation in scaling environments Ability to influence at senior level and operate cross-functionally Why This Role Senior leadership role with direct impact on global quality performance Opportunity to shape and scale quality systems in a high-growth environment Visibility with executive leadership and influence over strategic direction