Senior Design Assurance Engineer – Cardiovascular Med Devices

Actalent; Maple Grove (MN); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending Account (FSA)

Basic Life

401(k)

Retirement Plan

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

Actalent is seeking a Design Assurance Engineer in Maple Grove, MN, to lead design control and risk management for a next-generation catheter system. You will partner with Engineering, Regulatory, Clinical, and Operations to ensure global quality and regulatory compliance.

The role requires strong design controls knowledge, DHF ownership, and cross-functional leadership in a cardiovascular medical device environment. This is an onsite position with competitive benefits.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 5+ years in Design Assurance, Quality Engineering, Product Development Quality, or Medical Device Quality Systems.
• Experience in FDA-regulated medical device environments and ISO 14971 methodologies.

Responsibilities

• Lead design assurance activities 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/review risk analyses, RM plans, reports, and technical documentation.
• Collaborate with Engineering to ensure traceability and validation of requirements.
• Support regulatory submissions with technical and quality documentation.
• Mentor engineers and provide technical leadership across projects.

Skills

Design Assurance

Quality Engineering

Regulatory

Cross-functional

Technical Writing

Education

Bachelor's degree in Engineering

Biomedical/Life Sciences

Regulatory knowledge

Tools

Minitab

Job description

Actalent is seeking a Design Assurance Engineer in Maple Grove, MN, to lead design control and risk management for a next-generation catheter system. You will partner with Engineering, Regulatory, Clinical, and Operations to ensure global quality and regulatory compliance.

The role requires strong design controls knowledge, DHF ownership, and cross-functional leadership in a cardiovascular medical device environment. This is an onsite position with competitive benefits.