Stryker Group
Staff R&D Engineer - Sustaining & Model Development
Stryker Group, Irvine, California, United States, 92713
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.
About Inari Medical: Learn more about the Division
here . 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 Compensation: $100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Inari Medical is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal employment opportunities.
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here . 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 Compensation: $100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Inari Medical is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal employment opportunities.
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