We are currently seeking 2 R&D Engineers II to join a medical device R&D team supporting the design, development, testing, and launch of innovative products.
Now Hiring: R&D Engineer II | Medical Devices
Location: Santa Rosa, CA — 100% On-Site
Contract: July 27, 2026 – July 26, 2027
Schedule: 40 hours/week
Experience: 5+ years
Key Responsibilities
- Design, develop, analyze, and troubleshoot medical device products and processes.
- Create SolidWorks CAD parts, assemblies, and technical drawings.
- Develop and improve test methods, equipment, and protocols.
- Conduct root cause investigations and support failure analysis and process improvements.
- Perform protocol-based testing such as Design Verification (DV), Design Validation (DVal), and lot release testing.
- Prototype, test, and iterate mechanical components and systems.
- Document R&D activities through lab notebooks, engineering characterization studies, protocols, and test reports.
- Support design control activities, product/process development, and technology integration.
- Collaborate closely with Clinical, Quality, Manufacturing, Regulatory, Preclinical, Marketing, and other cross-functional teams.
- Support regulatory submissions and responses to regulatory agencies.
- Develop new test methods and equipment and train technicians on new processes.
- Prepare engineering change documentation for design, materials, and process changes.
Top Skills We're Looking For
Experience developing test methods and working with laboratory equipment is highly valued.
Strong Mechanical/R&D Technical Skills
- SolidWorks
- CAD part design and assemblies
- Technical drawings
- Mechanical prototyping
Protocol-Based Testing
Experience with DV, DVal, lot release, or similar protocol-driven testing.
Required Qualifications
- Bachelor’s degree in mechanical, Biomedical, Materials, Chemical Engineering, or related engineering discipline.
- 2+ years of relevant experience in R&D, Quality, Manufacturing, or a regulated industry.
- Experience working through different phases of medical device/product development.
- Strong problem-solving, technical writing, and communication skills.
- Ability to work independently as well as effectively within a cross-functional team.
- Proficiency with tools such as SolidWorks, Excel, PowerPoint, Word, and Minitab.
Nice to Have
- Knowledge of DOE and statistical techniques.
- Experience with structural heart catheter products, processing, or technologies.
- Failure analysis, process improvement, and change management experience.
- Experience with statistical methods such as tolerance intervals, normality testing, and t-tests.
If you have a strong background in medical device R&D, mechanical design, laboratory testing, and product development, we’d love to connect!