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 to New Product Development (NPD) 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 Design Quality Engineer 2 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 any type of visa sponsorship 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: bachelor's in engineering or a technically related field.

• Experience: 2-5 years' quality engineering experience in medical device or comparable regulated industry.

• Risk Management per ISO 14971 preferred

• Medical device software development per IEC 62304 preferred

• ISO 13485 preferred

• Time management, ability to plan and schedule multiple projects and tasks

• Effective Collaboration with cross functional teams

• Effective written/oral communication skills

• Accountability

• Travel Requirements: <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.