Senior Design Quality Engineer

Regulatory Jobs; Mansfield (MA); Hybrid; USD 97,000 - 120,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Paid Holidays

Flexible Vacation Time

Job summary

Smith+Nephew is seeking a Senior Design Quality Engineer in Mansfield, MA. You will support the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring safety, efficacy, and regulatory compliance.

Responsibilities include leading risk management, design quality oversight for verification and validation, investigations of complaints and CAPAs, and collaboration with cross-functional teams to meet quality and business goals.

Qualifications

• BS in Engineering or related field required.
• 5+ years in medical device or regulated environment.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.

Responsibilities

• Serve as Design Quality representative for product support and lifecycle management.
• Lead risk management, including FMEA and risk controls.
• Provide design quality oversight for design verification/validation and validation activities.
• Investigate complaints, nonconformances, CAPAs and post-market surveillance.
• Review and approve quality/engineering documentation for compliance.
• Collaborate with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical and Supplier Quality.

Skills

5+ years medical device quality

Cross-functional collaboration

Strong communication

Quality systems knowledge

Education

Bachelor of Science in Engineering or related field

Job description

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

Do you thrive in a collaborative environment where innovation, quality, and patient safety are at the heart of everything you do? As a Senior Design Quality Engineer, you will play a critical role in supporting the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring they remain safe, effective, compliant, and aligned with the needs of both patients and healthcare professionals. Based in Mansfield, MA, this is an opportunity to influence product quality, drive continuous improvement, and partner with cross functional teams to make a meaningful impact.

What will you be doing?

• Serve as the Design Quality representative for product support and lifecycle management activities, including product improvements, design changes, quality planning, investigations, and continuous quality enhancement initiatives
• Lead risk management activities including risk assessments, FMEA development and maintenance, implementation of risk controls, risk reviews, and verification of effectiveness
• Provide design quality oversight and approval for design verification and validation activities, sterilization validations, process validations, supplier qualifications, manufacturing process changes, and test methods
• Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments to identify root causes and drive corrective and preventive actions
• Review and approve quality and engineering documentation to ensure compliance with design controls, change control, risk management, and quality system requirements
• Partner closely with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality teams to support regulatory submissions, audits, inspections, and ongoing product support
• Act as a quality engineering resource for complex technical and compliance related issues, providing guidance and influencing decisions that impact product quality, patient safety, and business objectives
• Identify and drive continuous improvement opportunities through analysis of quality data, product feedback, risk management outputs, and operational performance metrics
• Provide technical leadership, training, guidance, and mentorship to support effective decision making, accountability, compliance, and quality excellence

What will you need to be successful?

• Bachelor of Science degree in Engineering or a technically related field
• 5+ years of experience in the medical device industry or another highly regulated environment
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements
• Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management
• Demonstrated ability to solve complex quality challenges and influence cross functional stakeholders
• Excellent communication, collaboration, and problem solving skills
• CQE and/or Six Sigma certification preferred

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. Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, 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. Flexibility: Hybrid Work Model (for most professional roles). Training: Hands On, Team Customized, Mentorship. Extra Perks: Discounts on fitness clubs, travel and more!

The anticipated base compensation range for this position is $96,750 - $120,000 USD annually (or hourly) 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. 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.

Smith+Naphew 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.