Process Development Engineer I (Santa Ana, CA) at Medtronic in Santa Ana, California

Job Description:

Careers that Change Lives
A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

A Day in the Life

Be a part of a dynamic team that designs and develops manufacturing processes for new heart valve therapies from concept through design transfer and product launch. This process development team is committed and driven in our mission to revolutionize the way we manufacture heart valves while producing a high-quality product for our patients and customers.

In this role, you will act under the general supervision of an Engineering Manager and within product development teams on multiple assignments of varying scope and complexity. Most of your work will involve close collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation.

Responsibilities may include the following and other duties may be assigned.

• Process Technologies: Support the exploration and development of new process technologies that can ultimately be incorporated into new product development projects or existing manufacturing lines. Such activities include, but are not limited to, the following:
  
  
  • Feasibility Studies: Support feasibility studies that explore new process technologies and evaluate its potential for application to bioprosthetic heart valve manufacturing. Analyze results and make recommendations.
• Process Development: Support new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields. Such activities include, but are not limited to, the following:
  
  
  • Manufacturing Studies: Plan and execute manufacturing studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
  • Pilot Line Development: Design manufacturing sequence of operations/workflow and specifications for equipment/tooling to ensure most efficient and productive layout.
  • Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations. Design and develop equipment and fixture requirements and its process parameters where applicable. Work with suppliers and internal stakeholders to realize design and ensure it meets specified requirements.
  • Define and generate all required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs, manufacturing instructions and procedures. Ensure compliance with internal procedures, GMP and regulations.
• Process Transfer: Support activities that are required for transfer of pilot line/ developed processes during product development phase to commercial operations. Such activities include, but are not limited to, the following:
  
  
  • Transfer Plan: Support the development and implementation of transfer plan activities. Ensure pilot line transfer, process transfer, and/or process technology is implemented efficiently and effectively into commercial production or receiving site.
  • Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability. Support test method development and validation where needed. Apply six sigma methodologies as appropriate.
  • Production Support and Trouble Shooting: Provide engineering support to manufacturing operation on routine basis. Investigate and address product related issues arising on the pilot line and production line following process transfer.
  • Continuous Improvement and Cost Analysis: Continually improve manufacturing method and processes to optimize product output, quality and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption.

Must Have: Minimum Requirements

• Bachelor of Science Degree in a Related Engineering Discipline (i.e., Mechanical, Biomedical, Industrial, Materials Science) required

Nice to Have

• 0-1 years of manufacturing and/or product/process development related experience
• Solid interpersonal skills and ability to work in a team environment
• Basic understanding of statistical techniques and analysis
• Demonstrated problem-solving and critical thinking experience
• Solid oral and written communication skills, including presentation skills
• Experience with Solidworks
• Previous experience working in a clean room environment
• Experience with cardiovascular and/or tissue-based products

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 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)