Senior Design Quality Engineer (Mansfield, MA) **This position is not offering any type of visa transfer or sponsorship now or in the future**What will you be doing?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.
Responsibilities include, but not limited to:
- 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.
- Attend cadaveric labs with customers (sales, marketing, surgeons) to build understanding of user needs and conduct design validation/usability.
- 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.
- Works cross-functionally to influence key stakeholders and provides training, leadership, and mentorship to teams and junior engineers.
What will you need to be successful?- Education: Bachelor of Science in Engineering or technically related field
- Licenses/ Certifications: CQE or Six Sigma preferred
- Experience: +5 years experience in the pharmaceutical/medical device industry or related regulated industry.
- Competences: FDA QSR, ISO 13485, ISO 14971, strong collaboration and communication.
- Physical Demands: Mostly sitting, light lifting
- Travel Requirements:
The anticipated base compensation range for this position is $96,750 $145,000 USD annually. 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. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.
You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
- Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
- Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
- Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Training: Hands-On, Team-Customized, Mentorship
- Extra Perks: Discounts on fitness clubs, travel and more!
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