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. 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