Sr. Design Assurance Engineer

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

Our client, a growing medical device company, is adding a Senior Design Assurance Engineer to play a key role in the development and commercialization of an innovative device.

This is an opportunity to work on a complex Class III implantable device as the company advances toward significant regulatory and commercialization milestones, including PMA and CE Mark approval.

The Senior Design Assurance Engineer will work at the intersection of R&D, Quality, Regulatory, Clinical, and Operations, with significant ownership of design controls, risk management, technical documentation, and Design History File (DHF) activities.

This role is ideal for someone who enjoys being close to product development and wants the visibility and breadth of responsibility that comes with working in a smaller, fast-paced medical device organization, andsomeone who wants to be close to the technology and involved in more than one narrow piece of Design Assurance.

Your role with the company:

• Lead design assurance activities throughout the product lifecycle, from new product development through commercialization.
• Own and support design control activities, including design inputs and outputs, design reviews, verification and validation, and design transfer.
• Lead the development and maintenance of Design History Files (DHF), ensuring documentation is accurate, traceable, complete, and audit-ready.
• Author and review risk management documentation in accordance with ISO 14971, including risk analyses, FMEAs, risk management plans, and reports.
• Evaluate new and revised industry standards, identify compliance gaps, and drive remediation activities.
• Author and review technical documentation supporting regulatory submissions, including protocols, reports, and risk documentation.
• Partner cross-functionally with R&D, Clinical, Operations, Regulatory Affairs, and Quality to ensure design and development activities meet applicable requirements.
• Support FDA, notified body, and internal audits and inspections, particularly those involving design and development documentation.
• Support manufacturing process and equipment qualification activities, including IQ, OQ, and PQ.
• Identify and drive continuous improvement opportunities across design assurance, quality systems, and product development processes.
• Mentor junior engineers and provide technical leadership across projects and cross-functional initiatives.

Desired Profile:

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