Quality Engineer

Job Description

• Support quality engineering efforts throughout the product development lifecycle for medical device programs

• Develop, review, and execute design verification plans, protocols, and reports

• Ensure product designs meet customer requirements, regulatory expectations, and quality standards

• Create verification documentation and assess testing strategies to confirm design performance

• Analyze test results and documentation to determine compliance with design requirements

• Partner closely with hardware, software, test, and project engineering teams to proactively identify risks and resolve quality concerns

• Review engineering data and verification results to ensure requirements have been successfully met

• Participate in design reviews and provide quality engineering guidance throughout product development

• Communicate quality risks, issues, and project status effectively across cross-functional teams

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related discipline

• 5+ years of relevant Quality Engineering experience

• Experience supporting design verification and/or validation activities

• Understanding and familiarity with quality engineering industry standards (e.g. AS9100, ISO13485, ISO9001)

• Experience working within regulated industries such as Medical Devices, Aerospace, Defense, Space, or similar

• Strong understanding of product development and engineering verification processes

• Ability to write, review, and execute verification protocols and documentation • Medical device quality engineering experience

• Experience supporting Class II or Class III medical devices

• Background with electronic products, printed circuit board assemblies (PCBAs), or hardware development

• Electrical engineering background or strong electronics experience

• Familiarity with robotic surgery systems or complex electromechanical products

• Leadership potential and interest in future growth opportunities

• Experience reviewing technical test data and determining compliance to requirements