Process Development Engineer II

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. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

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 the Structural Heart & Aortic Advanced Manufacturing (AME) Engineering team in Santa Ana. The role involves designing and developing cutting‑edge technologies for the manufacture of bioprosthetic heart valves.

• 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, collaboration with manufacturing sites, and leveraging automation or mechanization opportunities to enhance yield and reduce COGS.
• Support process development, characterization, and validation (IQ, OQ, PQ) activities to support new product introduction.
• Collaborate with cross‑functional teams (primarily R&D, Operations and Quality) to define, execute, and deliver on New Product Development requirements.
• Compile, document, and present all learnings to project and functional teams (e.g., Technical Reviews, Design Reviews, Project Dashboards, process development reports).
• Participate in functional initiatives that support the continuous improvement of the Process Development organization.
• Support the development and implementation of transfer plan activities; ensure pilot line transfer, process transfer, and/or process technology are implemented efficiently and effectively into commercial production or receiving site.
• Generate and execute plans for equipment qualification and process validation; develop plans to 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‑related 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.

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

• Experience using statistical techniques and analysis.
• Experience with designing tooling/fixture design and qualification.
• Experience with Solid Works.
• Experience working in and/or designing for a clean‑room environment.
• Experience with cardiovascular and/or tissue‑based products.

The above statements describe the general nature and level of work performed by employees assigned to this position. Reasonable accommodations can be made to enable individuals with disabilities to perform the essential functions of this job.

Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excl. PR) locations (USD): $80,800.00 – $. 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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Benefits include 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;
Simpl…