Smith & Nephew
Senior Design Quality Engineer (Mansfield, MA)
Mansfield, MA · Senior
Sponsorship not specifiedDetected 5 days ago
Process ImprovementFDA RegulatoryMedical DevicesLeadershipCollaborationMentoring
About the role
- Do you want to work in a collaborative environment that promotes innovation while prioritizing care for each other and our patients?
- The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location.
- It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.
Responsibilities
- Design quality engineer on new product development cross-functional core team.
- Responsible for leading risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.
- Responsible for leading quality design transfer activities including test method validation / measurement systems analysis and incoming inspection.
- Support other design transfer activities, including process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).
- Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities.
- Provide quality input to product user needs, design inputs, design specifications and design outputs (including analysis/definition of critical to quality features).
- Support design verification testing, design validation and usability testing.
- Assists in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits. Includes leading design control gap assessments (DHF audits).
- Leads identification and implementation of process improvement initiatives which require cross-functional and multi-site collaboration.
- Senior Design Quality Engineer (Mansfield, MA)
Requirements
- Bachelor of Science in Engineering or technically related field
Nice to have
- CQE or Six Sigma preferred
Compensation
- The anticipated base compensation range for this position is $96,750 $145,000 USD annually.
Benefits
- Discounts on fitness clubs, travel and more!
- Unlimited., life, culture, and benefits at S+N.
- Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Company info
- Attend cadaveric labs with customers (sales, marketing, surgeons) to build understanding of user needs and conduct design validation/usability.
- If so, join our Smith+Nephew team as a Senior Design Quality Engineer and be part of a cross-functional team responsible for New Product Development for sports medicine joint repair products.
- A Senior Design Quality Engineer will be part of a cross-functional team for new product development to deliver safe and effective products to the market by ensuring all aspects of design controls are robust and comply with company polices and governmental regulations.
- Explore our website and learn more about our mission, our team, and the opportunities we offer.
Visa & Work Authorization
- This position is not offering any type of visa transfer or sponsorship now or in the future**
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This listing is sourced directly from Smith & Nephew's careers page and normalized into a canonical job model.