Senior Design Assurance Engineer - MedTech Class III

Custom Search Inc.; Maple Grove (MN); On-site; USD 120,000 - 170,000; Full time

Job summary

Custom Search Inc. is seeking a Senior Design Assurance Engineer to drive design controls, risk management, and DHF development for a Class III implantable medical device.

You will collaborate across R&D, Regulatory, Clinical, and Quality to ensure audit-ready documentation and robust design history files. The role involves oversight of design assurance activities through development and commercialization, with opportunities to influence standards, scoping, and continuous improvement in a

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or equivalent.
• 5+ years of medical device experience in design assurance, product development, or quality engineering.
• Working knowledge of FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.
• Demonstrated experience with design controls, risk management, design documentation, and DHF.
• Experience with Nitinol processing (forming, heat treatment, electropolishing, or surface finishing is a plus).
• Knowledge of ISO 5840 and ISO 10993-1.
• Experience using statistical analysis tools such as Minitab.
• Ability to travel up to 10%.

Responsibilities

• Lead design assurance activities throughout the product lifecycle, from development through commercialization.
• Own and support design control activities including inputs/outputs, reviews, verification, validation, and transfer.
• Lead DHF development and maintenance to ensure audit readiness.
• Author and review risk management documentation per ISO 14971, including risk analyses and FMEAs.
• Evaluate new standards, identify gaps, and drive remediation.
• Prepare documentation for regulatory submissions (protocols, reports, risk docs).
• Collaborate with R&D, Clinical, Operations, Regulatory, and Quality to meet requirements.
• Support audits and inspections by regulators and internal teams.
• Assist manufacturing qualification activities (IQ, OQ, PQ).
• Identify continuous improvement opportunities across design assurance and quality systems.
• Mentor junior engineers and lead cross-functional initiatives.

Skills

Design assurance

Design controls

Risk management

Regulatory knowledge

Quality engineering

DHF

FMEAs

ISO 14971

Nitinol processing

Minitab

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Minitab

Job description

Custom Search Inc. is seeking a Senior Design Assurance Engineer to drive design controls, risk management, and DHF development for a Class III implantable medical device.

You will collaborate across R&D, Regulatory, Clinical, and Quality to ensure audit-ready documentation and robust design history files. The role involves oversight of design assurance activities through development and commercialization, with opportunities to influence standards, scoping, and continuous improvement in a