Senior Engineering Program Manager (Quality, Medtech)

TL;DR

Senior Engineering Program Manager (Quality, Medtech): Leading quality and reliability efforts in cardiac surgery product development with an accent on regulatory compliance (FDA CFR, MDR, ISO 13485) and design assurance. Focus on managing cross-functional quality teams, defining quality strategies, and ensuring robust product development processes and documentation.

Location: Onsite in Brooklyn Park, Minnesota, United States of America

Salary: $168,800.00 - $253,200.00 USD

Company

hirify.global is a global healthcare technology corporation dedicated to alleviating pain, restoring health, and extending life through medical innovations.

What you will do

• Lead quality and reliability initiatives for Cardiac Surgery products, ensuring compliance with regulatory standards.
• Serve as the Quality Core Team Member, coordinating quality teams and managing functional work from design concept to commercialization.
• Develop quality functional strategies, plans, and schedules, and manage program resource allocation and budget.
• Review and approve Design History File documentation for traceability, testability, and compliance.
• Proactively drive strategic quality, reliability, and safety improvements through risk management and DRM initiatives.
• Act as an independent quality reviewer, guiding program teams on robust quality strategies and documentation.

Requirements

• Bachelor’s degree with a minimum of 7 years of relevant experience in quality or engineering OR an Advanced degree with a minimum of 5 years of relevant experience.
• Must have US work authorization, as indicated by US-specific benefits and location.

Nice to have

• Minimum of 2 years of program management experience.
• Experience in Design Assurance Engineering, Reliability Engineering, Post-Market Quality Engineering, Quality Systems, Operations Quality Engineering, or Supplier Quality Engineering.
• Working knowledge of multiple quality disciplines (reliability, safety, compliance).
• PMP certified and proficient in leading cross-functional teams.
• Experienced practitioner of Design for Reliability and Manufacturability (DRM).

Culture & Benefits

• Competitive salary and flexible benefits package, including health, dental, and vision insurance.
• Health Savings Account, Healthcare Flexible Spending Account, Life insurance, and Long-term disability leave.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Focus on diversity, innovation, and cultivating a workforce that reflects patients and partners.