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Medtronic

Process Development Engineer II

Medtronic, Santa Ana, California, United States, 92725

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Overview

We anticipate the application window for this opening will close on 11 Nov 2025. 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. Roles and Responsibilities

A Day in the Life

The Process Development Engineer II will support teams driving technology innovation with emphasis on improving quality technical rigor and developing state-of-the-art mechanized and semi-automated systems. At our Structural Heart & Aortic Advanced Manufacturing (AME) Engineering team in Santa Ana Medtronic plc we focus on designing and developing cutting-edge technologies for the manufacture of bioprosthetic heart valves in the Cardiovascular Portfolio. Our Engineers are directly involved in the development of innovative products and processes for use in medical procedures. The role requires onsite work a minimum of 4 days per week to foster professional growth and cross-functional collaboration, with travel of less than 10% to enhance collaboration and ensure successful project completion. As an engineer you will actively participate in all areas of new product development for bovine and porcine heart valves, including: Technology Development & Advancement Process Development Mechanization & Semi-Automation Vendor Management & Project Management Process Technologies

You will support teams driving technology innovation with emphasis on improving quality technical rigor and developing state-of-the-art mechanized and semi-automated systems. Activities include, but are not limited to: Support feasibility or proof of principle studies that explore new process technologies and evaluate their potential for application to bioprosthetic heart valve manufacturing Analyze results and make recommendations Drive post-launch process improvements and cost-reduction initiatives through structured problem solving in collaboration with manufacturing sites; leverage automation or mechanization opportunities to enhance yield and reduce COGS Process Development

You will use DRM methodology and 3-D drawing to develop best-in-class processes and manufacturing lines for the manufacture of our heart valve product ranges. Activities include: Support process development characterization and validation (IQ, OQ, PQ) for New Product Introduction Collaborate with cross-functional teams (R&D, Operations, and Quality) to define, execute, and deliver on New Product Development requirements Compile, document, and present learnings to project and functional teams (e.g., Technical Reviews, Design Reviews, Project Dashboards, process Development reports) Participate in functional initiatives that support continuous improvement of the Process Development organization Process Transfer

You will support activities required for transfer of pilot line/developed processes during product development to commercial operations. Activities include: Develop and implement transfer plans; ensure pilot line transfer and process transfer into commercial production or receiving site Generate and execute plans for equipment qualification and process validation; evaluate process capability; support test method development and validation where needed Provide engineering support to manufacturing operations on a routine basis; investigate and address product issues arising on the pilot line and production line following process transfer Partner with cross-functional teams (Operations, Quality, and R&D) to assess and implement engineering solutions that enhance process capability, reduce variability, and strengthen product robustness throughout the lifecycle Requirements

Bachelor of Science Degree in a related engineering discipline (e.g., mechanical, biomedical, industrial, materials science) 2 years in manufacturing environment and/or product/process development Nice to Have

Experience using statistical techniques and analysis Experience with designing tooling/fixture design and qualification Experience with SolidWorks Experience working in and/or designing for a clean room environment Experience with cardiovascular and/or tissue-based products Physical Job Requirements

The above statements describe the general nature and level of work performed by employees assigned to this position. They are not an exhaustive list of all required responsibilities and skills. The physical demands described are representative of those necessary to perform the essential functions. Reasonable accommodations may be made for individuals with disabilities. For office roles: employees are regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers. 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 and offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S. locations (excl. PR): $80,800 - $121,200. 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. The offered rate 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. The following benefits and additional compensation are available to regular employees: 401(k) plan with employer match, health/dental/vision insurance, Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability, paid time off, paid holidays, Employee Stock Purchase Plan, and more. Some benefits may not apply in all locations. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic

We lead global healthcare technology and attack challenging health problems by seeking solutions. Our mission to alleviate pain, restore health, and extend life unites a global team. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. Learn more about our business, mission, and 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, disability, race, religion, gender, sexual orientation, gender identity and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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