Senior Engineering Program Manager - Quality Core Team Member

Medtronic • Brooklyn Park, MN

4d • $171,200 - $256,800 • Onsite

About The Position

The Senior Engineering Program Manager role is for a Quality Core Team Member directly supporting new product development in CardioVascular Surgery. The role is responsible for managing the extended quality team as well as acting as the lead Design Assurance Engineer for the respective new product development program(s). CardioVascular Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies include: Surgical heart valves, Cardiac OR solutions (e.g., blood management, cannulae), Extracorporeal life support, Coronary artery bypass grafting (CABG) solutions, and Advanced endovascular therapies across the entire aorta.

Requirements

• Bachelor’s degree
• 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Unrestricted U.S. work authorization (for roles below Principal level).

Nice To Haves

• Medical device industry experience
• A minimum of 2 years of program management experience.
• Experience in two or more of the following functions: Design Assurance Engineering, Reliability Engineering, Post-Market Quality Engineering, Quality Systems, Operations Quality Engineering, Supplier Quality Engineering.
• Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance.
• Master’s degree in engineering or business administration.
• PMP certified.
• 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).

Responsibilities

• Support quality and reliability efforts for CardioVascular Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, and ISO 13485.
• Serve as the Quality Core Team Member; coordinate quality team members and ensure accountability for completing functional work within program deadlines from design concept to design transfer to early commercialization.
• Develop Quality functional strategies, plans, and schedules to meet project goals and manage risks.
• Represent Voice of Quality across all global Quality disciplines.
• Ensure quality requests are defined, implemented, and met (requests flow down) across the project.
• Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
• Maintain alignment and manage execution across global Quality disciplines.
• Communicate key program information to ensure Core Team and Quality leadership engagement and alignment.
• Plan and manage program resource allocation and budget.
• Identify quality program risks and implement risk burn down strategies.
• Ensure an effective transfer to global Post-Market Quality functions.
• Review and approve Design History File and other related documentation, including plans, requirements, design, development, test protocols, test reports, verification, and validation.
• Ensure all documentation meets reliability standards and follows QMS processes.
• Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
• Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
• Collaborates with R&D, systems engineering, and cross-functional teams to develop, qualify, and implement robust, repeatable, and compliant test method validations that ensure traceability and reliability of results.
• Proactively drive and champion strategic quality, reliability, and safety improvements through execution of the risk management process and DRM initiatives.
• Facilitate the development of the product risk management file.
• Ensure process is compliant to risk management procedures.
• Support hardware and software quality and reliability efforts for CardioVascular Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
• Enhance product development and program management processes to improve compliance.
• Act as an independent quality reviewer for CardioVascular Surgery product development programs, guiding respective program teams to robust and compliant quality strategies, documentation, and decisions.
• Provides guidance, coaching, and training to other employees within CardioVascular Surgery.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior