Location: Oakland, CA
Salary: $125,000.00 USD Annually - $150,000.00 USD Annually
Description: Senior Biomedical EngineerLocation: Oakland, CA - Hybrid
Compensation: $130,000-$150,000 annually
About the OpportunityA privately held medical device company developing innovative treatments for venous disease and lymphedema is seeking a
Senior Biomedical Engineer to join its R&D organization.
This is a highly hands-on senior technical contributor role focused on the development of
catheter-based medical devices from early concept through design verification, validation, design transfer, and commercial manufacturing.
The ideal candidate is a strong engineering generalist who enjoys working across
CAD, prototyping, testing, design controls, regulatory documentation, suppliers, and manufacturing. This person will have significant ownership of the technical development process and will work closely with Quality, Regulatory, Clinical, Marketing, and Manufacturing teams.
Key Responsibilities- Lead catheter-based medical device development from concept through design transfer and manufacturing handoff.
- Translate clinical, market, and user needs into design inputs, engineering requirements, and verification/validation strategies.
- Design catheter assemblies and components using CAD, with SolidWorks experience preferred.
- Create engineering drawings, apply GD&T, and perform tolerance analysis.
- Build, modify, and troubleshoot prototypes while driving rapid design iterations.
- Develop and execute mechanical, dimensional, durability, deliverability, and reliability testing.
- Author test protocols, reports, design rationales, and other technical documentation.
- Own Design History File (DHF) deliverables, including design inputs/outputs, traceability, risk management, V&V documentation, and design reviews.
- Develop technical content supporting FDA regulatory submissions such as 510(k), De Novo, IDE, or PMA.
- Manage suppliers and contract manufacturers, including qualification, design reviews, first article inspection, root-cause investigations, and process improvements.
- Support pilot and production line development, including fixtures, tooling, work instructions, inspection methods, and process controls.
- Lead or support design transfer and IQ/OQ/PQ planning.
- Manage project schedules, deliverables, risks, budgets, and cross-functional dependencies.
- Partner with Quality, Regulatory, Clinical, Marketing, and Manufacturing teams throughout the product lifecycle.
- Support preclinical studies and clinical trial preparation, including device readiness, training, and post-use evaluations.
- Ensure engineering activities comply with applicable FDA and medical device standards.
- Mentor junior engineers and technicians in engineering, testing, design controls, and development best practices.
Qualifications- Bachelor's or Master's degree in Biomedical, Mechanical, Materials, or a related engineering discipline.
- 7-10+ years of medical device development experience, with significant experience developing catheter-based devices.
- Demonstrated experience taking a Class II or Class III medical device from early development through design transfer and commercial manufacturing.
- Strong hands-on prototyping and device assembly experience, including processes such as bonding, tipping, reflow, assembly, and troubleshooting.
- Proficiency with SolidWorks or comparable CAD software.
- Experience developing DHF documentation and supporting FDA submissions.
- Strong knowledge of medical device design controls, risk management, ISO 14971, ISO 13485, and FDA 21 CFR 820.
- Experience working with suppliers and contract manufacturers.
- Experience supporting production line development, fixtures, work instructions, inspection methods, and process controls.
- Knowledge of design for manufacturability, process validation, and production scale-up.
- Demonstrated project management experience, including schedules, deliverables, risk management, and cross-functional execution.
- Strong written and verbal communication skills with the ability to operate independently in a fast-paced environment.
Preferred Experience- Energy-based or thermal ablation catheter systems, including RF, microwave, cryo, or similar technologies.
- Authoring substantial portions of 510(k), De Novo, IDE, PMA, or CE/MDR submissions.
- GLP preclinical studies or early clinical trials, including investigator training or field support.
- Biocompatibility, sterilization, packaging, and shelf-life testing.
- ISO 10993, ISO 11135, IEC 62366, or IEC 60601 experience.
- Statistical methods such as DOE, Gauge R&R, or Cpk.
- PMP or other formal project management training.
Work EnvironmentThis position involves a combination of office, laboratory, and pilot production environments. The successful candidate should be comfortable performing hands-on prototype assembly and bench testing.
The role may require the ability to lift and carry up to 50 lbs. and travel approximately
15-20% to suppliers, contract manufacturers, testing laboratories, and clinical or preclinical sites.
Why Join?This is an opportunity to take significant ownership of the development of innovative medical devices while working across the full product development lifecycle-from concept and prototyping through regulatory, validation, design transfer, and manufacturing.
BenefitsWe offer a comprehensive benefits package for eligible employees, including
medical, dental, vision, and additional benefits including paid time off, holidays, and other wellness programs designed to support employee health and well-being.
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