Design Quality Engineer (Andover, MA)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Reporting into the Quality Department, the Design Quality Engineer 2 has responsibility for providing Quality Engineering support of New Product Development activities for Hardware/Software products in the Sports Medicine franchise.

Works collaboratively with project team members to develop and manage project plans and activities related to new product development. The quality engineer is responsible for supporting the execution of design control and risk management activities for assigned projects in accordance with internal procedures and applicable standards/ regulations. 

**This position does NOT offer visa sponsorshp now or in the future**

What will you be doing?

• Support new product development and implementation of new hardware/software products via development of overall risk management file. Risk management planning, use/design/software failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.

• Support new product development of hardware/software products by participating on cross-functional core team. Provide quality input to product user needs, design inputs, software requirements, software detailed design specifications and design outputs (including analysis/definition of critical to quality features). 

• Support design verification testing, design validation and usability testing. Support as needed software and/or system verification/validation testing activities including protocol and use case development, test execution and report writing.

• Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities.

• Under Quality Team supervision support, manufacturing quality activities including measurement systems analysis, incoming inspection, control plans, process summaries and process failure mode effects analysis (FMEA).

• Assist in preparation for regulatory submissions and provide support during audits and inspections.

• Improve knowledge of design controls, risk management, testing, statistics, Design Verification and Validation, Measurements Systems, applicable Quality System standards/regulations.

What will you need to be successful?

• Education: B.S in Engineering or a technically related field

• Experience:

  • 2-5 years Quality Engineering experience in Medical Device or regulated industry

  • Risk Management per ISO 14971 preferred

  • Medical device software development per IEC 62304 preferred

  • ISO 13485 preferred

• Travel Requirements: up to 10%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, 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

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

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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.