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Principal Process Engineer

Irvine, CA 92604
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Principal Process Engineer


Irvine, California, United States

Requisition #:


Post Date:

Sep 24, 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 hands on Principal Process Engineer to work closely with RD, Operations and Quality in the development of new processes necessary to produce Delivery Systems/Coils/Other Medical Devices for 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, managing development builds, generating testing protocols and reports, and working with minimal direction for New Product Introductions.

**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 Engineering or a related degree

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

**Nice to Have**

Experience with design and implementation of custom equipment/ tools, fixtures and/or off the shelf equipment/ tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with RD, Manufacturing Engineering, Quality Engineering, and Operations.

Application of statistical and analytical methods such as SPC, SQC, and DOE.

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

Development of manufacturing documentation (MP, IP, BOM)

Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design)

Significant experience with Solidworks, AutoCad

Knowledge in materials associated with medical devices such as Metals (nitinol, cobalt chromium, platinum, stainless steel, aluminum, etc.).

Knowledge in Coils and Delivery System Manufacturing processes such as laser welding (similar/dissimilar materials), heat setting, braiding, crimping, swaging, cleaning processes, measurement systems etc.

Proficient in design and process FMECA, Process Validation and variability reduction applications.

Good verbal and written communication skills.

**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: 2020-09-29 Expires: 2021-02-05
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Principal Process Engineer

Irvine, CA 92604

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