Design Assurance Engineer

Design Assurance Engineer

A client of ours is seeking an experienced Design Assurance Engineer to support product development and lifecycle activities in a regulated environment. This role is responsible for ensuring that product designs meet quality, regulatory, and customer requirements, with a strong focus on risk management, design controls, and compliance. Candidates with medical device experience are highly preferred; however, experience in other regulated industries (e.g., aerospace, automotive, pharmaceuticals) will also be considered.

Location: Fridley or White Bear Lake, MN Salary: 100-130k, depends on experience

Key Responsibilities:

• Lead and support design assurance activities throughout the product lifecycle, from concept through commercialization and post-market.
• Ensure compliance with applicable regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC standards as applicable).
• Participate in design control processes, including design planning, inputs/outputs, verification, validation, and design transfer.
• Facilitate and contribute to risk management activities, including hazard analysis, FMEA, and risk mitigation strategies.
• Collaborate cross-functionally with R&D, Quality, Regulatory Affairs, Manufacturing, and suppliers to ensure design quality and compliance.
• Review and approve design documentation to ensure completeness, accuracy, and regulatory alignment.
• Support change control processes and assess the impact of design changes.
• Contribute to internal and external audits, including regulatory inspections.
• Drive continuous improvement initiatives related to product quality and development processes.

Required Qualifications:

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 5 years of experience in design assurance, quality engineering, or a related role within a regulated industry.
• Strong knowledge of design control requirements and risk management principles.
• Experience working within a Quality Management System (QMS).
• Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971 (or equivalent in other regulated industries).
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in cross-functional teams.

Benefits

• 5 days in office
• Base + 10% bonus
• Medical, Dental, & Vision with HSA and FSA plans
• PTO Plan
• Retirement plans including a 401K match
• Supplemental Life Insurance & Disability Plans