Senior Design Quality Engineer

Smith & Nephew; Mansfield (MA); Hybrid; USD 97,000 - 120,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Medical, Dental, Vision insurance

Job summary

Smith+Neu in Mansfield, MA is seeking a Senior Design Quality Engineer to support the sustaining and lifecycle management of Sports Medicine Joint Repair products. You will partner with Regulatory Affairs, Operations, R&D, and Manufacturing to drive quality excellence and ensure patient safety.

The role requires a BS in Engineering and 5+ years in medical devices or regulated spaces, with strong knowledge of QSR, ISO 13485, and ISO 14971.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years in medical device or highly regulated environment.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.

Responsibilities

• Serve as Design Quality representative for product support, lifecycle management, and quality improvement initiatives.
• Lead risk management activities including FMEA, risk controls, and verification of effectiveness.
• Provide design quality oversight for verification/validation activities and supplier qualifications.
• Lead investigations related to complaints, nonconformances, CAPAs, and post-market surveillance.
• Review and approve quality and engineering documentation for compliance with design controls and change control.

Skills

Risk management

Design quality

Cross-functional collaboration

Quality systems knowledge

CAPA & validation

Problem solving

Communication skills

Education

Bachelor of Science in Engineering

Job description

Life. Unlimited. At Smith+Neu 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+Neu 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.

Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Neu is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Neu a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.