Design Assurance Engineer - Quality & Regulatory Leader

manpowe; Fridley (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

5 days in office

Base + 10% bonus

Medical, Dental, & Vision with HSA and

PTO

401K match

Life Insurance & Disability

Job summary

manpowe is seeking an experienced Design Assurance Engineer in Minnesota to support product development and lifecycle activities in a regulated environment. The role emphasizes risk management, design controls, and regulatory alignment with FDA/ISO standards.

The ideal candidate will have 5+ years in design assurance or related quality roles within regulated industries, and a strong background in QMS, with cross-functional collaboration across R&D, Regulatory, and Manufacturing.

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).
• Excellent analytical, problem-solving, and communication skills.

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.

Skills

Analytical skills

Problem-solving

Communication

Education

Bachelor’s degree in Engineering or related field

Job description

manpowe is seeking an experienced Design Assurance Engineer in Minnesota to support product development and lifecycle activities in a regulated environment. The role emphasizes risk management, design controls, and regulatory alignment with FDA/ISO standards.

The ideal candidate will have 5+ years in design assurance or related quality roles within regulated industries, and a strong background in QMS, with cross-functional collaboration across R&D, Regulatory, and Manufacturing.