Design Assurance Engineer
Manpower
Minneapolis, United States of America
3 days ago
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
Senior Compensation
$ 130KJob location
Minneapolis, United States of America
Tech stack
Adobe InDesign
Failure Mode Effects Analysis
Job description
- 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.
Requirements
- 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 & conditions
- 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
