Senior Engineering Program Manager – Quality Core Team Member

Role Overview

• Support quality and reliability efforts for Cardiac 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.

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.
• 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).

Tech Stack

• PMP

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 (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)