Job Information
Insight Global Principal Supplier Engineer in Arden Hills, Minnesota
Job Description
The Principal Supplier Engineer serves as the technical lead responsible for integrating supplier designs, components, and manufacturing processes into regulated medical device products. This role partners closely with R&D, Quality, Operations, Regulatory, and external suppliers to ensure compliance with design controls, risk management, and global regulatory requirements. Core responsibilities include supplier design assurance, component and process qualification, validations, supplier audits, and CAPA investigations. The engineer evaluates supplier capabilities, manages supplier-driven changes, and mitigates supply and quality risks across the product lifecycle. This position plays a key role in ensuring product reliability, manufacturability, and patient safety while supporting new technology integration and commercialization.
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 HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
• Bachelor’s degree in engineering or related discipline
• Minimum of 8 years of technical experience working in Medical Device development processes
• Experience in design controls, risk management, process validation, and CAPA
• Design assurance experience while working in Medical Device development • Experience working with suppliers and familiar with the application of design controls and supplier
controls as per 21CFR820 and MDR
• Auditor of quality systems experience (ISO 13485 or similar)
• Self-driven and results oriented with strong data analytics and critical thinking skills
• Experience managing projects and working with cross-functional teams to drive deliverables
• Organized and detail-oriented with ability to prioritize and manage multiple projects
• Strong interpersonal and communication skills to be able to work with other teams.