Design Assurance Engineer

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., + 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.

• 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.