Senior Design Assurance Engineer

• 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.

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., * 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.

• 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

Enhanced Compliance Inc.

• Arden Hills, MN About ECI ECIs mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of ex…