Job Details
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 discipline
- 4+ years of work experience in a regulated industry
- Proficient in 3D CAD modeling (Solidworks Preferred)
- Experience with design control
Preferred Qualifications:
- 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
- Pre-clinical and/or clinical experience
- 510(k) and/or PMA experience
- $100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.