Senior Engineering Program Manager - Quality Core Team Member
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
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:
• Surgical heart valves
• Cardiac OR solutions (e.g., blood management, cannulae)
• Extracorporeal life support
• Coronary artery bypass grafting (CABG) solutions
• Advanced endovascular therapies across the entire aorta
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). Elaborated responsibilities can be found below.
Quality Core Team Member 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.
Design Assurance Engineering Responsibilities
- 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.
Organizational Responsibilities
- 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.
Must Have: Minimum Requirements-
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile:
- 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.
Nice to Have
- 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).
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.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.