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At Stryker鈥檚 Inari Medical, we are transforming the lives of patients suffering from venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat life-threatening conditions with speed, safety, and precision. Join us in shaping the future of vascular health.
We are currently seeking a Staff R&D Engineer to join our team of passionate innovators and engineers.
The Staff R&D Engineer supports and leads project teams in the development of medical device products - this includes writing or verifying specifications, developing testing and product processes, and designing fixtures to ensure the concepts and/or prototypes meet requirements.
The Staff R&D Engineer actively participates in cross-functional product strategy development and in broader initiatives within the R&D organization.
Know more about the Division Here:
You will need to live within commuting distance to our 6001 Oak Canyon STE 100, Irvine, CA office.
You will need to be in the office 5 days a week.
What you will do- Independently research, design, develop, modify, and verify mechanical components for medical devices while working cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success.
- Analyze and correct complex product design issues using independent judgment.
- Ensure traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations.
- Develop test methods, fixtures, and inspection processes to evaluate prototypes and materials as well as post-launch design changes at the material, component, and supplier level.
- Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations.
- Lead creation and refinement of engineering documentation, such as the Design History file.
- Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System.
- Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.
- Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process.
- Bachelor鈥檚 Degree in Mechanical Engineering, Biomedical Engineering or related discipline
- 4+ years of work experience
- Demonstrated mechanical engineering problem-solving skills
- Experience with design control.
- Experience in creating engineering drawings, models, applying GD&T, and CAE tools to optimize the design
- Adept at applying knowledge of materials and manufacturing processes to product design
- Experience in a highly regulated industry
- 510(k) and/or PMA experience.
$87,600 - $186,700 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
