Quality Engineer, Robotics (Pittsburgh, PA)

Quality Assurance Engineer, Robotics (Pittsburgh, PA)

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

The Design Quality Assurance Engineer interacts with development engineers to assure quality in design for medical devices, applications, and embedded software, aligned with domestic and international regulations. In this position you review hardware and software design input requirement specifications and interact with engineering staff to document design specifications and tests. With limited oversight, you will create and update risk assessments; coach engineers in completing FMEA analysis of hardware and software elements; review verification and validation test plans, test procedures, and test reports; and you will monitor progress to resolve anomalies in a bug tracking system. You will advise on completing product requirements, risk controls, design reviews, specification traces, verification / validation testing, and issue tracking; work with staff on validation methods that maintain compliance with regulations and standards; advise on use of quality assurance methods in development, release, and maintenance of medical device hardware and software used in testing and service functions.

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

What will you be doing?

• Complete product risk assessment, incorporating contributions from Research and Development (R&D) engineers.
• Review and approve requirement specifications and associated traces
• Complete or lead CSA on tools
• Mentor engineering staff in planning development tasks, writing design input requirement specifications, performing risk assessment, and completing FMEAs
• Review and advise on system verification and validation test plans and test procedures
• Oversee design change projects to assure quality and compliance
• Coordinate design review meetings to review all quality aspects of new and updated products
• Collaborate with Product Development Engineers to ensure quality considerations during the concept stage
• Develop various inspection techniques and procedures to ensure product integrity to design specifications
• Responsible for the writing, approval, and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures
• Work with other Quality Engineers and the Metrology Lab personnel on the development of all product gauging.
• Works with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems; assist each of these groups with capability studies and the application of statistical quality control

What will you need to be successful?

• Education: Bachelor's degree or higher in computer science, engineering, biomed, or related field
• Licenses/Certifications: Quality Engineer, Agile/SAFe Certifications desired
• 2+ years of experience in quality, development, or testing of large-scale medical device products in a regulated industry
• Working knowledge of some or all of the following quality assurance methods: requirement and design specifications, risk assessment, specification traces, unit test, integration test, regression test , user interface automated testing, and design/code review
• Understanding of ISO/IEC standards for design, development, and testing such as ISO/IEC 62304, ISO/IEC 14971:2012, IEC 60601, and IEC 62366 among others
• Preferred experience: Experience reviewing, and/or developing and executing manual and automated test suites; working in a variety of programming languages and AI as well as understanding Agile or SAFe environments

Location: Pittsburgh, PA - targeting local candidates

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: Committed to Welcoming, Celebrating and Thriving on Diversity, 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
• 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 is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward.

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.