Senior Design Quality Engineer, New Product Development Advanced
$85.5k - $142.5kStryker Orthopaedics
Stryker seeks a Senior Design Quality Engineer for new product development of surgical communications equipment. This hybrid role in Flower Mound, Texas involves leading design reviews, risk management, and regulatory compliance for surgical lights, tables, and booms from concept through commercialization.
Responsibilities
- Partner with R&D and cross-functional teams to define design requirements and manufacturing processes
- Lead risk management activities, design reviews, and ensure regulatory compliance and safety
- Drive design verification, validation, and user testing to support product launches
- Prepare quality documentation for regulatory submissions and product approvals
- Oversee design transfers to manufacturing and review inspection plans and drawings
Requirements
- Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related field
- 2+ years experience in highly regulated industry
- Design Quality Engineering experience
- Knowledge of risk management, design assurance, validation, and reliability testing
- Familiarity with medical device regulations and regulatory body interaction
- Hands-on new product development experience with medical devices
Compensation: $85,500–$142,500 USD annual
Vacancy posted 1 day ago
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