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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
What you will do-
- Lead Design Assurance activities across multiple NPD programs and drive risk management (ISO 14971), usability engineering, and design controls
- Provide guidance on complex technical and quality decisions and mentor junior engineers and influence cross-functional teams
- Act as DAE Functional Lead (FL) for key programs
- Ensure timely completion of Design reviews (DRs); Risk management deliverables (RMP, DFMEA, RT, etc.) and Verification & validation strategy
- Proactively identify and mitigate program risks and partner with PD, Clinical, Regulatory, Quality, and Operations
- Influence decisions without authority and drive alignment on design inputs, outputs, and usability strategy
- Lead or contribute to Process improvement initiatives; improve DAE processes, templates, and ways of working and support audits and regulatory inspections
- Drive usability strategy across programs and Ensure integration of user needs into product design
- Lead/guide formative and summative evaluations
What you will need-
Required-
- Bachelor’s/Master’s in Engineering (Mechanical preferred); relevant experience in medical device / regulated industry
- Experience- 7 years - 10 years
- Strong knowledge of Design Controls (21 CFR 820 / ISO 13485); Risk Management (ISO 14971) and Usability (IEC 62366)
Preferred-
- Good communication and interpersonal skills.
- Exposure to Engineering Drawing, GD&T, Manufacturing process of metals and plastics.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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