Senior Quality Engineer
Smith&Nephew Germany · Pittsburgh, United States · full time · On site · today
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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
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.
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.
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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- Employer
- Smith&Nephew Germany
- Location
- Pittsburgh, United States · On site
- Contract
- full time