Onsite Senior Design Assurance Engineer – Medical Devices

Medtronic; Mounds View (MN); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with company match

Tuition assistance/reimbursement

Job summary

Medtronic is seeking a Senior Design Assurance Engineer for the Interventional Cardiology Therapy (ICT) team to support energy-based medical devices addressing hypertension. This on-site role requires 4 days per week in the office with limited travel (<10%).

You will lead design assurance, risk management, and validation activities across PDP projects to ensure regulatory approvals and successful market launches.

Qualifications

• Baccalaureate degree and 4+ years of relevant experience, or advanced degree with fewer years.
• Experience with medical device regulations and design assurance.
• Ability to manage complex data sets and perform statistical analyses.

Responsibilities

• Serve as the Design Assurance representative on PDP projects.
• Collaborate across a matrixed team to align priorities and meet timelines.
• Lead risk management to ensure FDA/ISO compliance.
• Lead and complete complex test method validation activities.
• Communicate progress to project leadership with clear, actionable updates.

Skills

Design Assurance

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Project management

Statistical analysis

Education

Baccalaureate degree

Master's degree

PhD

Tools

FTA

ANOVA

gage R&R

Reliability forecasting

Failure trending

Job description

Medtronic is seeking a Senior Design Assurance Engineer for the Interventional Cardiology Therapy (ICT) team to support energy-based medical devices addressing hypertension. This on-site role requires 4 days per week in the office with limited travel (<10%).

You will lead design assurance, risk management, and validation activities across PDP projects to ensure regulatory approvals and successful market launches.