Sr. Engineering Program Manager (Medtech)

TL;DR

Sr. Engineering Program Manager (Medtech): Managing the extended quality team and acting as the lead Design Assurance Engineer for new product development in Cardiac Surgery with an accent on quality, compliance, and improving patient outcomes. Focus on ensuring compliance with regulatory standards such as FDA CFR, MDR, and ISO 13485.

Location: Brooklyn Park, Minnesota, United States

Salary: $168,800.00 - $253,200.00

Company

hirify.global is a global healthcare technology company working to alleviate pain, restore health, and extend life.

What you will do

• Support quality and reliability efforts for Cardiac Surgery products, ensuring compliance with regulatory standards.
• Coordinate quality team members and ensure accountability for completing functional work within program deadlines.
• Develop Quality functional strategies, plans, and schedules to meet project goals and manage risks.
• Review and approve Design History File and other related documentation, ensuring all documentation meets reliability standards and follows QMS processes.
• Drive strategic quality, reliability, and safety improvements through execution of the risk management process.
• Provide guidance, coaching, and training to other employees within Cardiac Surgery.

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 in quality or engineering.
• Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance.
• Proficient in leading cross-functional teams in a matrixed organization.
• Proficient in product development processes and design controls.
• Experienced practitioner of Design for Reliability and Manufacturability (DRM).
• Must have unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice to have

• A 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.
• Master’s degree in engineering or business administration.
• PMP certified.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, dental, and vision insurance.
• 401(k) plan plus employer contribution and match.