TL;DR

Senior Engineering Program Manager (Medical Devices): Manage quality core team and lead design assurance engineering for cardiac surgery product development with an accent on regulatory compliance, quality strategy, and risk management. Focus on coordinating cross-functional teams, ensuring quality standards, and driving product reliability and safety improvements.

Location: Brooklyn Park, MN or Dexter, MI, United States

Salary: $168,800 - $253,200 USD annually

Company

Medtronic is a global leader in medical technology focused on alleviating pain, restoring health, and extending life through innovative healthcare solutions.

What you will do

  • Lead quality core team efforts supporting new product development in cardiac surgery, ensuring compliance with FDA, MDR, and ISO standards.
  • Act as lead Design Assurance Engineer, reviewing and approving design history files and related documentation.
  • Develop and implement quality functional strategies, risk management, and resource allocation plans.
  • Collaborate with R&D, regulatory, clinical, and global quality teams to align on quality and compliance requirements.
  • Drive strategic quality, reliability, and safety improvements through risk management and design for reliability initiatives.
  • Provide guidance, coaching, and training to team members and act as an independent quality reviewer for programs.

Requirements

  • Must be based in the United States with unrestricted work authorization.
  • Bachelor’s degree with minimum 7 years relevant experience in quality or engineering, or advanced degree with 5 years.
  • Strong knowledge of quality systems, regulatory standards (FDA CFR, MDR, ISO 13485), and design assurance processes.
  • Experience managing cross-functional teams and program resources.
  • Excellent communication skills to engage global quality leadership and stakeholders.

Nice to have

  • Program management experience (2+ years).
  • Experience in multiple quality disciplines including reliability, safety, and supplier quality.
  • Master’s degree in engineering or business administration.
  • PMP certification.
  • Experience with Design for Reliability and Manufacturability (DRM).

Culture & Benefits

  • Comprehensive health, dental, vision insurance, and flexible spending accounts.
  • 401(k) plan with employer match and incentive plans.
  • Paid time off, holidays, and employee stock purchase plan.
  • Supportive environment with commitment to diversity, equity, and inclusion.
  • Opportunities for career growth and continuous learning.