Engineer III Quality Design Assurance

Position Summary

The primary responsibility of the Quality Design Assurance Engineer III position is to serve as a core project team member supporting the development of complex medical device components assemblies and systems. This role represents the Quality Assurance function on multiple product and process development projects working cross-functionally to ensure development activities comply with applicable regulatory requirements customer requirements quality standards and Quality Management System procedures. The Quality Design Assurance Engineer III operates with a high degree of independence technical judgment and collaboration supporting design controls risk management verification and validation activities and design transfer to manufacturing to ensure robust manufacturable and compliant medical device products.

This is an onsite position in our Fridley MN location. We are open to hiring at the Engineer III or Senior level.

What Youll Do Every Day:

• Serve as the primary Quality Assurance Engineer on complex product and process development projects collaborating across crossfunctional teams to drive deliverables through the Product and Process Development Process while ensuring documentation accuracy completeness and compliance.
• Represent Quality Assurance in development activities by creating and maintaining Quality Plans requirements traceability and Risk Management Plans and by reviewing/approving Change Orders Deviations Verification/Validation protocols qualification reports and inspection procedures in alignment with design controls and QMS requirements.
• Design and/or specify inspection strategies test plans procedures and systems to ensure products meet specifications regulatory requirements customer needs and quality standards while providing periodic updates on quality status and development progress.
• Initiate review and approve Nonconforming Product dispositions; investigate inhouse nonconformances across components assemblies and finished devices; perform rootcause analysis; implement corrective actions; and monitor quality trends and complaint trends in collaboration with Regulatory Affairs.
• Lead and support continuous improvement initiatives including proposing solutions utilizing the CAPA system improving product quality process robustness and manufacturability and contributing to enhancements in quality systems processes and documentation.
• Support and interface with engineering manufacturing regulatory quality and operations teams to promote collaboration maintain compliance with the Quality Management System (QMS) reduce operational risk and provide input for Quality Management Reviews.
• Facilitate customer audits and assist with external audits such as FDA and ISO inspections ensuring readiness and alignment with regulatory expectations and complaint handling requirements.
• Provide mentorship and technical guidance to Quality Assurance Technicians and junior engineers; develop and monitor quarterly quality goals and objectives; and participate in company meetings training sessions and quality improvement initiatives.
• Other duties may be assigned as required.

What Were Looking For:

• Bachelor degree in engineering or related field strongly preferred; other relevant postsecondary education training and experience may be considered in lieu of a Bachelors degree.
• Minimum 5 years of relevant experience required.
• Experience in the medical device industry as a Quality Assurance Engineer strongly preferred.
• Experience with the use and application of gages inspection tools and test equipment.
• Practical experience and familiarity with ISO 13485 FDA Quality System Regulations Design Controls Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) ISO 14971 sterilization processes cleanroom environments and other applicable standards.
• Customer-focused mindset with the ability to work collaboratively across functional groups.
• Must be highly organized and able to manage multiple projects concurrently.
• Must possess practical knowledge related to the products supported by the position such as guidewires catheters leads electromechanical devices or related technologies.
• Must possess strong written and verbal communication skills team-building skills and basic PC skills including working knowledge of Microsoft Word Excel and Minitab.
• Must be able to read and interpret component and product specifications.
• Must be willing and able to travel between Fridley MN and White Bear Lake MN sites as needed.
• Must be willing to travel globally for projects on occasion up to 10% of the time.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $100000 and $126000 based upon a full-time schedule. This is a good faith estimate on the applicable salaries are determined by taking a variety of factors in account including but not limited to candidate qualifications geographic locations market conditions and internal position is bonus eligible with a target bonus of 10%.Our total compensation package includes eligibility for comprehensive medical dental and vision coverage a 401(k) plan with company match education reimbursement paid parental leave and paid time off.