Senior Software Design Quality Engineer (Andover, MA)

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

At Smith+Nephew, we craft and manufacture technology that takes the limits off living! In this critical quality role as a Senior Software Design Quality Assurance Engineer. You will interact with the NPD and Product Sustain teams to assure quality in design for medical devices and application software. You review design inputs, testing strategies, and test procedures and interact with the project team to help write and conduct, or review document design specifications and unit/integration/verification tests. You will advise on completing product requirements, risk controls, unit tests, integration tests, design reviews, specification traces, verification/validation testing, and issue tracking.  You will mentor staff on validation methods that maintain compliance with regulations and standards and advise on use of quality assurance methods in development, release, and maintenance of software used in production, testing, and service functions.

What will you be doing?

• Oversee New Product Development and/or software design change projects to assure quality and compliance.

• Complete product risk assessment, incorporating contributions from various functions.

• Review and approve software requirement specifications and associated traces.

• Complete CSV/CSA on Quality System Tools

• Mentor engineering staff in planning software development tasks, writing software design input requirement specifications, performing risk assessment, and completing FMEAs on software elements.

• Review and approve software unit tests.

• Review and advise on system verification and validation test plans and test procedures.

• Participate in or lead audits, CAPAs, and NCs where necessary

• Working knowledge of the following Design Quality Assurance methods: requirement and design specifications, risk assessments, specification traces, unit tests, integration tests, regression tests, user interface, automated testing, and design/code reviews

What will you need to be successful?

• Education:

  • Bachelor’s Degree in Engineering, Computer, or other Science discipline, or equivalent with 6+ years of job-related experience in a quality/automated testing/code writing role. 

  • Master’s Degree in Engineering, Computer, or other Science discipline with 4+ years of experience in a quality/automated testing/code writing role.

• Licenses/ Certifications:  Software Quality Engineer Certification preferred

• Experience:

  • 2 years plus in Software development using ISO/IEC 62304 and Risk Management using ISO/IEC 14971

• Comfortable working as an embedded team member, working as a supporting function, working remotely, and/or working with others who are remote

• Quality mentality and thinking outside the box, ability to envision multi-product relationships

• Experience working in regulated industries, preferably medical device, including FDA’s 21 CFR 820/ISO 13485

• BDD/TDD, Linux, Angular, React CLI, Jest, Specflow/Cucumber

• Experience with test automation and management tools, such as Jasmine, JUnit, NUnit, Cucumber, SpecFlow

• Experience using JavaScript, Gradle, Git, JUnit, and/or NUnit

• Experience testing on IOS and Android operating systems

• Experience working with Agile methods, including SAFe

• Experience developing and executing manual and automated test suites

• Experience working in a variety of programming languages and environments

• Travel Requirements: <20%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
  Work/Life Balance:  PTO, 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

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.