New · posted Oct 16
Smith+Nephew · Medical Devices
Senior Quality Engineer
- Pittsburgh, PA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
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 you need
3 ways to qualify
Master’s
+ 4+ years of 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
- or
Bachelor’s
+ 6+ years of experience
Bachelor's Degree in Engineering, Computer Science, or related discipline with 6+ years of relevant experience; OR
- or
Associate
+ 8+ years of experience
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 Qualificationsnice to have
- 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!
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.
Pay and benefits
Smith+Nephew didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
401k matching program
Medical, dental and vision
Health Savings Account with employer contribution
Tuition reimbursement
Paid holidays and flexible time off
Parental leave
Where you'll work
Pittsburgh, PAHybridOpen in Maps (opens in a new tab)
More jobs in Pittsburgh, PAEqual opportunity, accessibility and legal noticesSmith+Nephew's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 16, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US285 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $104,000 | $122,500 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Smith+Nephew's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems10
- Lab testing and methods8
- Quality systems and risk8
- Collaboration and leadership8
- GMP and compliance5
- Validation and qualification4
- Documentation and SOPs1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Smith+Nephew on Regulatory Jobs
- 10
- Open roles
- 9
- Distinct roles
- 7
- Locations
By discipline
- Quality6 60%
- Regulatory4 40%
By level
- Senior & Principal5 50%
- Manager2 20%
- Associate & Specialist2 20%
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Senior Quality Engineer at Smith+Nephew
Open until filled.