Senior Design Assurance Engineer – Medical Devices

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

Benefits offered by this job

Health, Dental and vision insurance

Health Savings Account

Tuition assistance/reimbursement

401(k) plan with employer match

Job summary

Medtronic is seeking a Senior Design Assurance Engineer for the Interventional Cardiology Therapy (ICT) team to lead design assurance across the product lifecycle. This role emphasizes robust design verification, risk management, and regulatory compliance to support regulatory approval and market launch.

The position requires on-site presence a minimum of 4 days per week and limited travel, with collaboration across cross-functional teams to deliver robust medical devices.

Qualifications

• Requires a degree and 4+ years of relevant experience, or Master's with 2+ years relevant experience, or PhD with 0 years relevant experience.
• Experience with FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971:2019
• Strong knowledge of design verification, validation, risk management, and regulatory compliance.

Responsibilities

• Serve as the Design Assurance representative on PDP projects, with dotted-line reporting to the Quality Core Team Member
• Collaborate across a matrixed team to align priorities, solve problems, and achieve project goals
• Plan and schedule activities to meet timelines
• Communicate progress to project leadership, presenting complex issues clearly
• Perform reliability analyses across requirements, architecture, interfaces, and design
• Lead risk management activities to ensure FDA/ISO compliance
• Lead and complete complex test method validation activities for system and capital equipment
• Drive continuous improvement in Design Assurance
• Identify, elevate, and resolve reliability and technical risks early
• Maintain up-to-date knowledge of regulatory compliance requirements
• Coordinate with test labs to complete design verification on time

Skills

Design Assurance

Regulatory compliance

Risk management

Reliability analysis

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

FTA

gage R&R

ANOVA

Reliability forecasting

Job description

Medtronic is seeking a Senior Design Assurance Engineer for the Interventional Cardiology Therapy (ICT) team to lead design assurance across the product lifecycle. This role emphasizes robust design verification, risk management, and regulatory compliance to support regulatory approval and market launch.

The position requires on-site presence a minimum of 4 days per week and limited travel, with collaboration across cross-functional teams to deliver robust medical devices.