Design Quality Engineer (Andover, MA)

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

We are currently seeking a Design Quality Engineer to help maintain the design integrity, safety, performance, and quality of our Advanced Wound Management medical devices.

This role plays a key part in ensuring new and existing products comply with global quality system regulations and applicable standards throughout the product lifecycle.

What will you be doing?

• Ensuring compliance with Design Control and Design Change activities independent of NPD and sustaining teams

• Reviewing and approving Design History Files (DHFs) and associated quality documentation

• Supporting verification and validation activities to ensure outputs meet design inputs

• Participating in risk analyses, design changes, and product testing activities

• Supporting the transfer of designs to manufacturing in collaboration with Operations and QA

• Reviewing and approving specifications for raw materials, intermediate products, and finished goods

• Generating and maintaining Risk Management Files in accordance with ISO 14971

• Contributing to Health Hazard Evaluations and Safety & Efficacy Review Board activities as needed

• Supporting accurate and compliant Instructions for Use (IFUs)

• Establishing and improving SOPs and Ways of Working (WoW) to support compliant product development

• Maintaining current knowledge of applicable standards, regulations, and best practices

What will you need to be successful?

• Bachelor's degree in a relevant engineering or life sciences discipline

• 2+ years of experience in a regulated environment

• Exposure to Design Control requirements for medical devices (ISO 13485)

• Exposure to Risk Management for medical devices (ISO 14971)

• Knowledge of FDA Quality System Regulation (QSR) and global quality systems

• Experience working with GMP and quality system standards

• Experience with medical device software development (ISO 62304) is preferred, not required

The anticipated base compensation range for this position is $81,750.00 - $122,500.00 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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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.