Senior Design Assurance Engineer — Medical Devices (Onsite)

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

Job summary

Medtronic in Minnesota is seeking a Senior Design Assurance Engineer to support energy-based medical device development. You will lead design assurance activities across the product lifecycle, driving risk management, design verification, and regulatory compliance with FDA and ISO standards.

The role requires onsite presence a minimum of 4 days per week, collaborative cross-functional work, and travel under 10%.

Qualifications

• Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
• Experience in medical device design verification and risk management is required
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971:2019 is preferred

Responsibilities

• Serve as the Design Assurance representative on PDP projects
• Collaborate across a matrixed team to align priorities and meet timelines
• Plan and schedule activities to meet project milestones
• Communicate progress to project leadership regularly
• Perform reliability analyses across requirements, architecture, interfaces, and design
• Lead risk management activities to ensure compliance with regulatory standards
• Lead and complete complex test method validation activities
• Drive continuous improvement in Design Assurance
• Work with test labs to complete design verification activities

Skills

Project management

Medical Device industry experience

Regulatory knowledge (FDA ISO)

Data analysis

Timeline management

Design controls

Engineering development

Education

Bachelor's degree in a relevant field

Master's degree (preferred)

PhD (optional)

Tools

FTA

ANOVA

Gage R&R

Job description

Medtronic in Minnesota is seeking a Senior Design Assurance Engineer to support energy-based medical device development. You will lead design assurance activities across the product lifecycle, driving risk management, design verification, and regulatory compliance with FDA and ISO standards.

The role requires onsite presence a minimum of 4 days per week, collaborative cross-functional work, and travel under 10%.