Engineering Manager

1 week ago

Santa Ana, United States Medtronic Full time

**Engineering Manager**

**Careers that Change Lives**

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Engineering Manager is responsible for leading a team of post-market quality engineers and technicians to own and execute post market surveillance activities. This role is also responsible for overall operation of the Returned Product Analysis (RPA) lab based at the Santa Ana site which supports multiple operating units (Structural Heart, Cardiac Surgery, etc.). This individual will work directly with the post market quality engineers and technicians who conduct product analysis and complaint investigations to ensure complaint files are closed in a timely manner. See additional responsibilities section for more details.

The Structural Heart and Aortic integrated operating unit offers mínimally-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.

**Key Technologies**:
Evolut R, PRO, PRO+ and FX TAVR systems

Melody Transcatheter Pulmonary Valve

Harmony Transcatheter Pulmonary Valve

Intrepid Transcatheter Valve System

Contegra Pulmonary Valved Conduit

Hancock Valved Conduit

Surgical Heart Valves such as - Mosiac Mitral Bioprosthesis, Hancock II, Freestyle and Avalus

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

**A Day in the Life**
- The Post Market Surveillance Manager works with the Post Market Quality leaders of Structural Heart, Cardiac Surgery and other operating units, as well as the Santa Ana site leadership to ensure the RPA lab operates in compliance with all Enterprise and Site-specific requirements.
- Manages day to day operations of the RPA lab, manage the workflow by assigning responsibilities and preparing/maintaining schedules. Oversee safe use of testing equipment and schedule regular calibration/maintenance.
- Closely monitors established leading indicators for complaint investigations, measures daily/weekly outputs and plans activities to course-correct as needed (burndown plans, etc.) to ensure overall complaint timeliness metric is sustained.
- This position will lead and/or support ongoing post market improvement initiatives focused on sustaining complaint timeliness metric, GMP/GLP in the RPA lab and improving PMS processes.
- Works with the Post-Market and Pre-Market Quality teams to ensure transfer of product knowledge and RPA lab readiness/commercialization readiness at the time of new product launches.
- Supports and facilitates Enterprise and internal/external audits as necessary, provides PMS expertise in the front and back room as needed.
- Provide technical input supporting submissions to regulatory bodies and governmental agencies.
- Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
- Lead and motivate team members through feedback and assignments. Establishes and maintains high levels of credibility. Collaborates effectively across the organization, build commitment and achieve results.

**MUST HAVE - MINIMUM REQUIREMENTS**:
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
- Bachelor’s degree in engineering, health science, or a technical discipline
- Minimum of 5 years of work experience in engineering, health science, technical discipline OR Advanced degree in engineering, health science, or a technical discipline with 3 years of work experience with 5 years of managerial experience.

**Nice to Have**
- Experience in managing teams, performance evaluations of direct reports.
- Advanced degree in engineering, science, or equivalent technical discipline
- Demonstrated understanding of implant procedures.
- Experience in a highly regulated industry, preferably implantable medical devices
- Knowledge of product development cycles including clinical and regulatory requirements
- Ability to coach and mentor engineering team members.

**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 inn

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