Senior Design Assurance Engineer

Location: Fridley, MN (Onsite) • Permanent / Full-Time

About the Opportunity

A leading global medical device development and manufacturing organization is seeking a Senior Quality Design Assurance Engineer to support the development of innovative, life-changing medical technologies. This role partners closely with engineering, manufacturing, regulatory, and quality teams to ensure products are developed, validated, and transferred into production in compliance with applicable regulatory and quality requirements. The ideal candidate is a highly experienced quality professional with a strong background in medical device product development, design controls, risk management, and quality systems.

Responsibilities

• Serve as the lead Quality Assurance Engineer on complex product and process development projects.
• Partner with cross-functional teams to drive project deliverables through established product development processes.
• Develop and maintain Quality Plans, Risk Management Plans, and requirements traceability documentation.
• Review and approve quality-related documentation including change orders, deviations, validation protocols, qualification reports, and inspection procedures.
• Design and implement inspection strategies, test plans, procedures, and quality systems to ensure compliance with specifications and regulatory requirements.
• Lead investigations of nonconforming products, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Monitor quality metrics, trends, and complaint data to identify opportunities for improvement.
• Support continuous improvement initiatives focused on product quality, manufacturability, and process robustness.
• Collaborate with engineering, manufacturing, regulatory affairs, and operations teams to ensure ongoing QMS compliance.
• Support customer audits and external inspections, including FDA and ISO audits.
• Mentor junior quality professionals and provide technical guidance to team members.
• Contribute to quality objectives, management reviews, training activities, and organizational improvement initiatives.
• Perform additional duties as required.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum of 8 years of relevant engineering or quality experience.
• Experience in the medical device industry, preferably within a Quality Assurance role.
• Knowledge of quality inspection methods, measurement systems, and test equipment.
• Strong understanding of:
  • ISO 13485
  • FDA Quality System Regulations (21 CFR Part 820)
  • Design Controls
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • ISO 14971 Risk Management
  • Sterilization processes
  • Cleanroom manufacturing environments
• Strong problem-solving and root cause analysis skills.
• Excellent written and verbal communication abilities.
• Ability to manage multiple projects and priorities simultaneously.
• Proficiency with Microsoft Office applications and quality/statistical tools such as Minitab.
• Ability to read and interpret technical drawings, specifications, and product requirements.
• Ability to travel between local Minnesota facilities as needed.

Preferred Qualifications

• Experience supporting products such as guidewires, catheters, leads, electromechanical devices, or similar medical technologies.
• Experience leading quality activities within product development programs.
• Prior mentoring or leadership experience.

Pay

Competitive base salary: $110,000 - $130,000

Benefits

• Annual bonus opportunity (target 10%)
• Comprehensive medical, dental, and vision coverage
• 401(k) with company match
• Paid time off and holidays
• Paid parental leave
• Tuition and education reimbursement
• Career development and advancement opportunities