Staff R&D Engineer Sustaining & Model Development
Staff R&D Engineer Sustaining & Model Development
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Job Description
At Strykers 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:
- Bachelors 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.
Required Experience:
Staff IC
Employment Type
Full-Time
