At Stryker’s 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.
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.
Learn more about the Division Here: Inari Medical
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.Conduct or design advanced prototyping and testing.Create benchtop models to simulate clinically relevant and challenging use conditions.Support Voice of Customer sessions internally and with clinicians.Analyze and correct complex product design issues using independent judgment. Ensure traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations.Support and execute segments of complex multifunctional teams to advance post-launch design changes at the material, component, and supplier level.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.What You Will Need:
Required Qualifications:
Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or related discipline4+ years of work experience in a regulated industryProficient in 3D CAD modeling (Solidworks Preferred)Experience with design controlPreferred Qualifications:
Experience in creating engineering drawings, models, applying GD&T, and CAE tools to optimize the designAdept at applying knowledge of materials and manufacturing processes to product designPre-clinical and/or clinical experience510(k) and/or PMA experience$100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.