Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
Are you passionate about software quality, risk management, and medical device compliance? We are looking for a Senior Design Quality Assurance Engineer to partner with cross-functional development teams and ensure the quality, safety, and regulatory compliance of medical devices and software applications throughout the product lifecycle.
This position plays a key role in new product development and design change projects, providing quality leadership, risk management expertise, and guidance on software validation, verification, and regulatory compliance.
What will you be doing?
- Lead Design Quality Assurance activities for new product development and design change projects.
- Complete and facilitate product risk assessments, including FMEAs and other risk management activities.
- Review and approve design input requirements, specifications, and traceability documentation.
- Review and approve software unit tests and support integration, verification, and validation testing activities.
- Complete Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for Quality System tools.
- Support audits, CAPAs, non-conformances, and compliance investigations as required.
- Mentor engineering teams on software development lifecycle best practices, risk management, and design control compliance.
What will you need to be successful?
Required Qualifications
Education & Experience
- Master's Degree in Engineering, Computer Science, or related discipline with 4+ years of experience in quality assurance, software testing, automation, or software development; OR
- Bachelor's Degree in Engineering, Computer Science, or related discipline with 6+ years of relevant experience; OR
- Associate Degree with 8+ years of relevant experience.
Technical Knowledge
- Strong understanding of Design Quality Assurance principles, including: Design requirements and specifications Risk assessments and risk management Requirements traceability Unit, integration, and regression testing Automated testing methodologies Design and code reviews.
- Experience applying ISO 13485, ISO 14971, and IEC 62304.
- Experience working within regulated industries, preferably medical devices.
- Knowledge of FDA Quality System requirements, including 21 CFR Part 820 and Quality Management System Regulations.
- Experience supporting software verification and validation activities.
- Ability to work effectively with geographically dispersed and cross-functional teams.
- Strong analytical, problem-solving, and communication skills.
- Ability to work independently with minimal supervision.
Preferred Qualifications
- Software Quality Engineer Certification.
- Experience with Agile development methodologies, including SAFe.
- Experience developing and executing manual and automated test suites.
- Experience with BDD/TDD methodologies.
- Experience with Linux environments.
- Experience with Angular, React CLI, Jest, SpecFlow, Cucumber, Jasmine, JUnit, or NUnit.
- Experience testing mobile applications on iOS and Android platforms.
- Experience working with multiple programming languages and software development environments.
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.
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Explore our website and learn more about our mission, our team, and the opportunities we offer.
Skills Required
- Master's degree in Engineering, Computer Science, or a related discipline with 4 or more years of relevant experience
- Bachelor's degree in Engineering, Computer Science, or a related discipline with 6 or more years of relevant experience
- Associate degree with 8 or more years of relevant experience
- Experience in quality assurance, software testing, automation, or software development
- Understanding of design quality assurance, design requirements, specifications, risk management, requirements traceability, and software testing
- Experience with ISO 13485, ISO 14971, and IEC 62304
- Experience working in regulated industries, preferably medical devices
- Knowledge of FDA Quality System requirements, including 21 CFR Part 820 and Quality Management System Regulations
- Experience supporting software verification and validation activities
- Ability to work with geographically dispersed and cross-functional teams
- Strong analytical, problem-solving, and communication skills
- Ability to work independently with minimal supervision
- Software Quality Engineer Certification
- Experience with Agile development methodologies, including SAFe
- Experience developing and executing manual and automated test suites
- Experience with BDD and TDD methodologies
- Experience with Linux environments
- Experience with Angular, React CLI, Jest, SpecFlow, Cucumber, Jasmine, JUnit, or NUnit
- Experience testing mobile applications on iOS and Android platforms
- Experience with multiple programming languages and software development environments
Smith & Nephew Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Smith & Nephew and has not been reviewed or approved by Smith & Nephew.
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Healthcare Strength — Medical, dental, and vision plans are paired with a global mental‑health program for employees and families, indicating a robust core health package.
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Retirement Support — U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
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Leave & Time Off Breadth — Generous holiday, paid volunteering leave, and flexible work models point to broad time‑off options.
Smith & Nephew Insights
What We Do
Smith+Nephew 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+Nephew 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. Please note: not all products referred to may be approved for use or available in all markets.
