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Staff R&D Engineer - Sustaining & Model…
- Stryker (Irvine, CA)
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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 (https://www.inarimedical.com/)
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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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