Senior Design Assurance Lead – Medical Devices

ACTalent; Minneapolis (MN); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

FSA

Basic Life

401(k) Retirement Plan

Paid Holidays

PTO

Parental Leave

Job summary

ACTalent is seeking a Design Assurance Engineer to lead design assurance activities for a next-generation medical device, collaborating with Engineering, Regulatory, Clinical, and Operations teams to meet global quality and regulatory standards.

You will drive design controls, maintain the DHF, and lead risk management per ISO 14971, while mentoring engineers and guiding cross-functional teams through product development and regulatory submissions.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years in Design Assurance, Quality Eng, or Medical Device Quality Systems.
• Experience in FDA-regulated medical devices.
• Strong Design Controls and product development processes.

Responsibilities

• Lead design assurance across new product development and commercialization.
• Drive design control activities including planning, inputs, outputs, reviews, verification, validation, and design transfer.
• Own DHF strategy, maintenance, and audit readiness.
• Lead risk management per ISO 14971 and regulatory requirements.
• Author and review risk analyses, risk management plans, reports, protocols, and technical documentation.
• Partner with Engineering to ensure traceability, verification, and validation of requirements.
• Support regulatory submissions through development of technical and quality documentation.
• Collaborate with Clinical, Operations, Manufacturing, and Regulatory Affairs for project execution.
• Assess new regulations and standards and lead compliance gap assessments.
• Support FDA inspections, notified body audits, and internal quality audits.
• Lead continuous improvement to strengthen processes and quality systems.
• Mentor engineers and provide technical leadership across projects.

Skills

Design Assurance

Quality Engineering

Regulatory Knowledge

Risk Management

Design Controls

Technical Writing

Project Leadership

FDA Experience

Cross-functional

Communication Skills

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Minitab

Job description

ACTalent is seeking a Design Assurance Engineer to lead design assurance activities for a next-generation medical device, collaborating with Engineering, Regulatory, Clinical, and Operations teams to meet global quality and regulatory standards.

You will drive design controls, maintain the DHF, and lead risk management per ISO 14971, while mentoring engineers and guiding cross-functional teams through product development and regulatory submissions.