Process Engineer II at Medtronic in Irvine, 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. Join us as we engineer the extraordinary!

Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare.Learn more about Medtronic benefits and compensation at the bottom of this job description.

We are seeking a hands-on Process Development Engineer II to work closely with R&D, Operations and Quality in the development of new processes necessary to produce Coils/Stents/Braids Medical Devices for a lean manufacturing environment. This will position will be onsite in Irvine, California.

A Day in the Life

As a Process Development Engineer II, you will develop new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working with minimal direction for New Product Introductions.

Responsibilities will include but are not limited to:

• Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.
• Develop fixtures, tooling, and equipment.
• Develop process specifications which ensure user needs are met.
• Perform process characterizations and qualifications (IQ/OQ/PQ).
• Manage required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues.
• Comply with applicable FDA and international regulatory laws/standards.
• Perform other duties as assigned or required.

Must Haves - Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume.

• Bachelor's Degree in a technical discipline
• Minimum 2 years of relevant engineering experience, or advanced degree with a minimum of 0 years of relevant engineering experience

Nice to Have

• Bachelor's degree in Engineering (preferably Mechanical, Electrical, or Biomedical)
• 2+ years of experience developing products and/or manufacturing processes in the medical device industry
• Knowledge of SolidWorks and engineering statistics
• Some experience or knowledge with Coils/Stents/Braid Manufacturing processes such as laser cutting, laser welding (similar/dissimilar materials), heat setting, electropolishing, braiding, crimping, swaging, cleaning processes, etc.
• Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design).
• Knowledge of design and process FMECA, process validation, and process control.
• Knowledge of design for manufacturability and lean methodologies.

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.

Benefits & Compensation

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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). Learn more about MIP and benefits here .

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Physical Job Requirements

The physical demands described within the A Day in the Life 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.