Job description: Senior R&D Engineer - Interventional Medical Devices About the Role We are seeking an experienced Senior R&D Engineer to lead and support the design and development of vascular, neurovascular, coronary, and electrophysiology medical devices, including stents, catheters, delivery systems, and other minimally invasive interventional products. This role is responsible for supporting the complete product development lifecycle, from initial concept and feasibility through design verification, validation, commercialization, and manufacturing. The position will also provide ongoing sustaining R&D support for released products. The ideal candidate will have hands-on experience in a regulated medical device environment and a strong understanding of FDA Design Controls, ISO 13485 requirements, and structured, phased product development processes. Key Responsibilities Lead and support medical device product development activities under FDA Design Controls Contribute across Phase I, Phase II, Phase III, and Phase IV development Design and modify components and assemblies using SolidWorks Develop prototypes for stents, catheters, delivery systems, and related vascular devices Define verification and validation strategies and develop written test protocols Execute design verification testing DVT, validation testing, and engineering analyses Document test results and technical findings in formal reports consistent with process requirements Develop, implement, and refine inspection and test methods for finished products and incoming components Evaluate measurement systems, test equipment accuracy, and method repeatability Assist in specification development for new and existing products Interpret engineering drawings, GD&T, schematics, and technical documentation Analyze statistical data to evaluate product performance, reliability, and quality expectations Investigate internal product failures and customer complaints to determine technical root cause Recommend and implement engineering improvements to enhance product reliability and performance Design for manufacturing & work with Operations to ensure proper interpretation of drawings, work instructions, and production documentation Support packaging development, labeling activities, and commercialization readiness Collaborate with cross functional teams including Quality, Operations, and Manufacturing Engineering Work with domestic and international suppliers and development partners Perform bench testing, dimensional inspections, and product performance evaluations Qualifications B.S. in Mechanical Engineering, Biomedical Engineering, or related technical field 4-6 years minimum of medical device experience Experience with vascular, neurovascular, electrophysiology, coronary, catheter, stent, or minimally invasive devices preferred Strong knowledge of Design Controls and regulated development processes Proficiency in SolidWorks Experience bringing products from prototype through commercialization Experience with design verification testing, inspections, and statistical analysis Strong troubleshooting and engineering problem solving skills Excellent technical documentation and communication skills Preferred Experience with catheter manufacturing, electrophysiology or implantable devices Experience coordinating with global suppliers and manufacturing partners Hands-on experience in medical device startups or small organizations

Job Type:

Full-time Benefits:

401(k) Dental insurance Flexible spending account Health insurance Life insurance Paid time off Retirement plan Vision insurance Ability to

Commute:

Arcadia, CA 91006 (Required)

Work Location:

In person

Pay:

$85,000.00 - $90,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Life insurance Paid time off Retirement plan Vision insurance

Work Location:

In person