Principal Quality Engineer - Risk Management & Design Controls

We are seeking a highly experienced Principal Engineer to lead specialized initiatives in risk management, design controls, and product development. This role is critical to driving quality and compliance across electromechanical and software-integrated components. The ideal candidate will be a hands-on expert who thrives in a dynamic environment, collaborates closely with cross-functional teams, and is committed to long-term growth.
Key Responsibilities
Lead and guide Process FMEAs and Design FMEAs (DFMEAs), ensuring risks are identified, assessed, and accepted appropriately.
Own and drive change controls, change orders, and field failure investigations.
Review and update engineering prints and documentation to reflect design changes and risk mitigations.
Collaborate with R&D and manufacturing teams to ensure seamless integration of risk management into product lifecycle.
Apply ISO 14971 for medical device risk management, with hands-on implementation experience.
Support non-conformance (NC) and CAPA processes with deep understanding of root cause analysis and corrective actions.
Provide technical leadership in design control and manufacturing process improvements.
Serve as a subject matter expert in ISO 13485, guiding teams through design change and control procedures.
Participate in new product development (NPD) and support at least one product line.
Travel domestically and internationally as needed to support global operations.
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 learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Required Skills & Experience
- Bachelor's degree in Engineering (Mechanical, Electrical, or related field).
- 7-8 years of experience in engineering roles with increasing responsibility.
- Strong background in mechanical and electromechanical systems, with exposure to software components.
- Proven expertise in risk management, design controls, and manufacturing processes.
- Hands-on experience with ISO 14971 and ISO 13485.
- Excellent communication and leadership skills; able to guide teams and make decisive technical contributions.
Nice to Have Skills & Experience
- ASQ Certified Quality Engineer (CQE)
- LEAN/Six Sigma Certification
- Background in software and electrical engineering - a strong plus.
- Demonstrated stability and commitment in previous roles.
- Strong team player with a proactive, challenge-ready mindset.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.