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1+ months

Principal Process Engineer

Irvine, CA 92604
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Principal Process Engineer


Irvine, California, United States

Requisition #:


Post Date:

Jun 19, 2020

**Principal Process Engineer**

**Careers that Change Lives**

Impact patient outcomes. Come for a job, stay for a career.

We are a rapidly growing, global medical device manufacturer that is committed to developing innovative endovascular technologies for neurological applications. Creative, competent people with a passion for enhancing healthcare around the globe have driven our success. Heres where you come in!

We are seeking a hands-on Principal Process Development Engineer to work closely with Suppliers, RD, Operations and Quality in the development of Equipment/Fixtures and processes necessary to produce Stents/Delivery Systems in a lean manufacturing environment. The ideal candidate will have prior experience working in the medical device industry developing new manufacturing processes, implementing and qualifying production equipment and methods internally and at supplier sites, managing development builds, generating testing protocols and reports, and working with minimal direction for New Product Introductions with a focus on electronic products.

**Day in the life:**

Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions through frequent interaction with RD, 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 equipment and process characterizations and qualifications (IQ/OQ/PQ).

Work with outside OEM Suppliers, internal/external machine shops, and/or other departments/groups.

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.

Lead and Develop all manufacturing related documentation necessary to fulfill PDP, regulatory and Quality System requirements.

May have supervisory responsibility for junior engineers technician staff.

Perform other duties as assigned or required.

**Must Have: Minimum Qualifications**

-Bachelors degree in Electrical Engineering or related disciplines

- 7+ years of experience with Bachelors Degree OR 5+ years of experience with an Advanced Degree

**Nice to Have**

7+ years of experience in the Medical Device Industry

Experience leading development and/or manufacturing of custom medical device equipment including component level and electromedical device assembly manufacturing.

Experience working with suppliers of electronics components, subassemblies, and finished devices.

Experience working with suppliers on manufacturing process development and validation.

Knowledge of SolidWorks and engineering statistics.

Process background (development, capability, optimization, validation) within a regulated industry.

Experience leading a variety of projects.

Experience with manufacturing line layout, capacity analysis, and line balancing.

Proficient with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design).

Ability to read electronics schematics and mechanical drawings.

Experience being on project teams tasked with new product development and successful transfer into manufacturing.

Experience troubleshooting and documenting evaluations of finished devices, sub-assemblies, and component failures.

Experience with 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**Physical Job Requirements**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-06-02 Expires: 2020-09-28
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