Engineering Program Manager, Santa Ana, CA

We anticipate the application window for this opening will close on - 26 Sep 2025At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.# **A Day in the Life**Careers That Change Lives The Structural Heart and Aortic integrated operating unit offers minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. This position will primarily support programs in Mitral and Tricuspid therapy areas. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. This position is based in Santa Ana, CA.**Responsibilities may include the following and other duties may be assigned.*** Direct, develop, and coordinate the activities of Program/Project Managers in supporting SH&A implant development programs.* Knowledge in product development, project management, and commercialization in the medical device industry.* Develop and monitor schedules, plans, tasks, and priorities, ensuring a streamlined workflow.* As a Quality Lead, oversee and ensure the delivery of all quality-related deliverables throughout the medical device product development lifecycle. Leverage in-depth knowledge of design controls, risk management (ISO 14971), and regulatory standards such as ISO 13485 and FDA 21 CFR Part 820 to guide cross-functional teams.* Lead efforts in design verification and validation, ensuring compliance with quality system regulations and readiness for internal and external audits.* Drive continuous improvement initiatives, mentor team members on quality best practices, and maintain robust documentation to support product and process excellence.* Drive problem-solving sessions, maintaining a sense of urgency and holding team members accountable to commitments.* Anticipate and mitigate risks, balancing time, schedule, cost, and quality, while adhering to safety and regulatory standards.* Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management.* Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.* Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.* Monitors documentation maintenance throughout all phases of research and development. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.* Anticipate and mitigate risks, balancing time, schedule, cost, and quality, while adhering to safety and regulatory standards.* Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.* Completes risk analysis studies of new design and processes.* Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.* Ensures that corrective measures meet acceptable reliability standards.* Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.* May develop mathematical models to identify units, batches or processes posing excessive failure risks.* As necessary, proposes changes in design or formulation to improve system and/or process reliability.* May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.* Strong communication and teamwork skills; must possess excellent relationship building skills with direct reports, peers, and senior leaders* Must be able to lead cross-functional discussions; driving towards alignment, decisions, resolutions when necessary* Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.* Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.**Must Have: Minimum Requirements:****To be considered for this role, please ensure the minimum requirements are evident on your resume.*** Requires a Bachelor's Degree and minimum of 5 years relevant experience, or Master’s Degree with a minimum of 3 years of relevant experience or PhD with 0 years of relevant experience.**Nice to Have:*** Experience working under regulations of the FDA, notified bodies, and other regulatory agencies for successful commercial launches* Product launch experience working with Global teams**Physical Job Requirements:**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. (ADA-United States of America).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. Learn more about our benefits **.**In addition to Base Salary, this position is eligible for a short-term incentive plan, which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about Medtronic Incentive Plan (MIP) **here****.**The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. **About Medtronic:**Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.**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 #J-18808-Ljbffr

Created: 2025-09-18