Systems Engineer - R&D
Stryker
Work Flexibility: Onsite
What You Will Do:
The R&D Engineer supports the design changes of commercialized devices and international submissions in the Inari Medical Division, including writing or verifying specifications, designing device improvements and fixtures, and conducting testing to adhere to product requirements and regulatory standards.
Design, develop, and verify mechanical components for medical devices under supervision, contributing to the overall engineering process.Support prototyping and testing, including bench-level evaluations and verification against design requirements.Conduct root cause analysis and problem-solving activities while ensuring traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations.Assist in developing test methods, fixtures, and inspection processes to evaluate new prototypes and materials as well as post-launch design changes at the material, component, and supplier level.Contribute to Design History File documentation and understand design inputs, clinical use, and regulatory standards.Perform statistical analysis and present findings that support product and process decisions.Collaborate cross-functionally with internal teams (R&D, Quality, Regulatory, etc.) to support successful project outcomes.What You Will Need:
Required Qualifications:
Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials/Materials Science) & 0 years of work experienceFoundational understanding of engineering principles, tools, and design practicesFamiliarity with analysis tools and statistical methodsBasic knowledge of materials and manufacturing methods relevant to product design and developmentAbility to read and interpret complex drawings and technical documentationStrong communication skills to convey technical information internally and interface effectively with physiciansPreferred Qualifications:
Regulated industry experience (medical device)Experience with Solidworks$79k - $123k salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
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