Staff R&D Engineer - Sustaining & Model Development

Stryker • Irvine, CA

85d • $100,000 - $165,000

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• $100k - $165k salary plus bonus eligible + benefits.

What This Job Offers

• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees