Quality Engineer, Robotics (Pittsburgh, PA)

About the position

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.

Responsibilities

• 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.
• Participate as a trainer in Quality Assurance and Manufacturing employee training programs.
• Work 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.

Requirements

• 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.
• Excellent analytical, problem solving, organizational, and communication skills.
• Familiarity with ISO/IEC standards for design, development, and testing such as ISO/IEC 62304, ISO/IEC 14971:2012, IEC 60601, and IEC 62366 among others.
• Experience reviewing, and/or developing and executing manual and automated test suites.

Benefits

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Hybrid Work Model (For most professional roles)
• Hands-On, Team-Customized, Mentorship
• Discounts on fitness clubs, travel and more!