At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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 asFDA CFR MDR andISO 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:

• Bachelors 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.
• Masters 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 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.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.