Design Quality Engineer (Mansfield, MA)

Smith & Nephew; Mansfield (MA); Hybrid; USD 75,000 - 95,000; Full time

Job summary

Smith & Nephew is seeking a Design Quality Engineer 2 to join their team in Mansfield, MA. The role involves leading quality initiatives in new product development for sports medicine joint repair products, ensuring compliance with industry standards. Ideal candidates will have a BS in Engineering and relevant industry experience, contributing to innovative solutions that improve patient care.

Benefits

401k matching

Stock options

Tuition reimbursement

PTO and holidays

Flexibility in work model

Discounts on fitness and travel

Qualifications

• 2+ years in the medical device or regulated industry.
• Experience in risk management, quality controls, and design verification.
• Strong analytical and problem-solving skills.

Responsibilities

• Responsible for risk management planning, FMEA, and design quality.
• Participate in cadaveric labs for design validation and usability testing.
• Assist in regulatory submissions and audits.

Skills

Risk management

FMEA

Quality design transfer activities

User needs assessments

Education

Bachelor of Science in Engineering

Job description

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

Do you want to work in a collaborative environment that promotes innovation while prioritizing care for each other and our patients? Do you want to develop products that enable friends and family to live life unlimited? If so, join our Smith+Nephew team as a Design Quality Engineer 2 and be part of a cross-functional team responsible for New Product Development in sports medicine joint repair products.

**This position does not offer visa sponsorship now or in the future**

What will you be doing?

A Design Quality Engineer 2 will be part of a cross-functional team for new product development, ensuring all design controls are robust and comply with company policies and regulations. Responsibilities include, but are not limited to:

• Design quality engineer on new product development cross-functional core team.
• Responsible for risk management planning, FMEA, risk control, mitigation, and verification of effectiveness.
• Responsible for quality design transfer activities including test method validation, measurement systems analysis, incoming inspection, process validations, and FMEA.
• Responsible for developing and releasing engineering design documentation, supporting design reviews, and design history file activities.
• Provide quality input to product user needs, design inputs, specifications, and outputs.
• Support design verification and validation testing, including usability testing.
• Participate in cadaveric labs with customers to understand user needs and conduct design validation/usability testing.
• Assist in regulatory submissions and defend design control elements during audits, including leading gap assessments.
• Identify and implement process improvements through cross-functional collaboration.

What will you need to be successful?

• Education: Bachelor of Science in Engineering or related field.
• Experience: 2+ years in the medical device or regulated industry.
• Travel Requirements: As needed.

You. Unlimited

We believe in creating the greatest good for society, investing in our people and patients.

Inclusion and Belonging: Committed to diversity and inclusion. Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Why you'll love it here:

• Your Future: 401k matching, stock options, tuition reimbursement.
• Work/Life Balance: PTO, holidays, flex holidays, community service days.
• Your Wellbeing: Medical, dental, vision, HSA, assistance programs, parental leave, fertility and adoption support.
• Flexibility: Hybrid work model for most professional roles.
• Training: Hands-on, team-based, mentorship programs.
• Perks: Discounts on fitness, travel, and more.

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Smith+Nephew is an equal opportunity employer, fostering diversity and inclusion.

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