Senior Design Quality Engineer; Mansfield, MA

Life Unlimited.

At Smith+ Nephew we design and manufacture technology that takes the limits off living. Do you want to work in a collaborative environment that promotes innovation while prioritizing care for each other and our patients? Do you want to develop products that will enable friends and family to live life unlimited? 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.

• This position does not offer any type of visa transfer or sponsorship now or in the future.

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 compliant with company policies and governmental regulations.

• Design quality engineer on new product development cross‑functional core team.
• Lead risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation, and verification of effectiveness.
• Lead 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).
• Develop and release 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.
• Attend cadaveric labs with customers (sales, marketing, surgeons) to build understanding of user needs and conduct design validation/usability.
• Assist in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits, including leading design control gap assessments (DHF audits).
• Lead identification and implementation of process improvement initiatives requiring cross‑functional and multi‑site collaboration.
• Work cross‑functionally to influence key stakeholders and provide training, leadership, and mentorship to teams and junior engineers.

• Education:
  
  Bachelor of Science in Engineering or related technical field.
• Licenses/Certifications:
  
  CQE or Six Sigma preferred.
• Experience:
  
  +5 years in the pharmaceutical/medical device industry or related regulated industry.
• Competencies:
  
  FDA QSR, ISO 13485, ISO 14971, strong collaboration and communication skills.
• Physical Demands:
  Mostly sitting, light lifting.

The anticipated base compensation range for this position is $96,750–$145,000 USD annually. Base pay is based on factors such as knowledge, skills, experience, and location. In addition to base pay, we provide competitive bonus and benefits including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays annually, 8 hours of volunteer time, and a variety of wellness offerings such as EAP.

• Inclusion and Belonging – Committed to welcoming, celebrating, and thriving on inclusion and belonging. Learn more about employee inclusion groups on our website.
• 401(k) matching program, 401(k) plus program, discounted stock options, tuition reimbursement.
• Work/Life Balance – Flexible personal/vacation time off, paid holidays, flex holidays, paid community service day.
• Wellbeing – Medical, dental, vision, health savings account (employer contribution $500+ annually), employee assistance program, parental leave, fertility and adoption assistance program.
• Training – Hands‑on, team‑customized, mentorship.
• Discounts on fitness clubs, travel and more.

Smith+ Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.