Sr. Staff R&D Engineer
About The Position
Stryker Peripheral Vascular is hiring a Senior Staff R&D Engineer to support development of a next-generation mechanical thrombectomy device. The role provides technical ownership of complex structural mechanical design challenges while remaining hands-on with design, prototyping, testing, and problem-solving. As a subject matter expert, the engineer guides critical technical decisions, mentors developing engineers, and collaborates with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management. This position combines deep technical expertise and technical leadership with hands-on medical device product development. It is onsite five days a week in Irvine, California, with 10% travel.
Requirements
- Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- Minimum 6 years of professional engineering experience.
- Professional experience in structural mechanical design and development of components using nitinol, shape-memory materials, or comparable metallic alloys.
- Professional experience developing products within a regulated medical device environment, including design controls, risk management, and test-method development.
- Must be legally authorized to work in the U.S. and not require employment-based sponsorship now or in the future.
Nice To Haves
- Experience developing nitinol-based components, including material behavior, processing, fatigue, durability, and structural performance.
- Experience developing catheter-based, stent, vascular, thrombectomy, structural heart, or other mechanically complex medical devices.
- Experience using SolidWorks, engineering drawings, GD&T, or CAE tools to develop and iterate complex mechanical designs.
- Experience progressing medical device products through design freeze, design verification, and design transfer, including DFM.
Responsibilities
- Lead structural mechanical design, development, prototyping, testing, and technical evaluation of complex catheter-based medical device components and subsystems through design development, design freeze, verification, validation, and design transfer.
- Serve as a technical subject matter expert for nitinol and metallic-alloy component development, including material behavior, processing, structural performance, fatigue, durability, and design optimization.
- Evaluate existing designs, test results, technical limitations, and new concepts; rapidly develop and iterate prototypes to meet component, subsystem, and overall device requirements.
- Develop complex mechanical designs and models using SolidWorks, engineering drawings, GD&T, CAE analysis, materials selection, and DFM principles.
- Lead technical trade-off decisions, root-cause investigations, risk assessments, and design modifications using engineering analysis, hands-on prototyping, and laboratory testing.
- Establish test methods and design verification strategies, including risk-based testing, statistical analysis, sample-size rationale, and technical documentation supporting medical device design controls.
- Partner with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to integrate component designs into the overall device and address manufacturing requirements throughout development.
- Mentor engineers on advanced engineering principles, technical problem-solving, design controls, risk management, and medical device product-development practices.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
