Senior Design Assurance Engineer Manpower Engineering - 3.8 Fridley, MN Job Details Full-time $100,000 - $130,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications Accreditation standards (regulatory compliance area) ISO standards Quality risk management Regulatory/legal compliance standards in production Design controls Biomedical regulatory compliance Cross-functional communication Full Job Description 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.

Job Title:

Design Assurance Engineer 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