Design Quality Engineer

Smith Nephew; Mansfield (MA); Hybrid; USD 74,000 - 112,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Paid Holidays

Flexible Time Off

Job summary

Smith+ Nephew is seeking a Design Quality Engineer in Mansfield, MA to support the Sports Medicine Joint Repair portfolio. You will partner with cross-functional teams to ensure quality, regulatory, and lifecycle requirements are met across the product lifecycle.

The role focuses on sustaining engineering, design changes, risk management, and design controls, with opportunities to influence product performance and patient safety while collaborating with Regulatory, R&D, and Manufacturing teams.

Qualifications

• BS degree in engineering or related technical discipline.
• At least 2 years in medical device industry or another regulated environment.
• Knowledge of FDA QSR, ISO 13485, ISO 14971, Design Controls, Risk Management methodologies, CAPA and complaint handling processes.
• Strong analytical, communication, collaboration, and problem-solving skills.
• Ability to develop and implement solutions to complex quality challenges.

Responsibilities

• Support product lifecycle management activities, including design changes, investigations, and quality plans.
• Lead and support risk management activities, including risk assessments, FMEAs, risk controls, and effectiveness reviews.
• Review and approve design verification and validation activities, process changes, supplier qualifications, and process validations.
• Investigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
• Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
• Provide technical quality guidance and influence decisions impacting product performance, compliance, and patient safety.
• Drive continuous improvement initiatives using quality metrics and post-market data.

Skills

Analytical skills

Communication

Collaboration

Problem solving

Education

Bachelor of Science in engineering

Job description

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

Are you passionate about quality, innovation, and patient safety? Do you enjoy working across functions to ensure medical devices remain safe, effective, and compliant throughout their lifecycle?

Join Smith+ Nephew as a Design Quality Engineer and play a key role in supporting our Sports Medicine Joint Repair portfolio while helping improve outcomes for patients around the world.

As a Design Quality Engineer, you will partner with cross‑functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.

Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization

What will you be doing?

• Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
• Lead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.
• Review and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.
• Investigate complaints, nonconformances, CAPAs, post‑market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
• Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
• Provide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.
• Drive continuous improvement initiatives using quality metrics, post‑market data, and operational performance insights.

What will you need to be successful?

Required Qualifications

• Bachelor of Science degree in Engineering or a related technical discipline.
• Minimum of 2 years of experience in the medical device industry or another regulated environment.
• Working knowledge of: FDA Quality System Regulations (QSR) ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes
• Strong analytical, communication, collaboration, and problem‑solving skills.
• Ability to develop and implement solutions to complex quality challenges.

Preferred Qualifications

• Certified Quality Engineer (CQE).
• Six Sigma certification.
• Experience supporting sustaining engineering and product lifecycle management.
• Experience participating in audits, inspections, and regulatory submissions.

Physical Demands

• Primarily seated work with occasional light lifting.

Travel Requirements

• Less than 10% travel.

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!

The anticipated base compensation range for this position is $74,250 to $111,500 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, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.

In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.

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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.

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