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1+ months

Principal Manufacturing Engineer

Medtronic
Irvine, CA 92617
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Principal Manufacturing Engineer

Location:

Irvine California, California, United States

Requisition #:

19000FZV

Post Date:

Aug 21, 2019


**Principal Manufacturing 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 Manufacturing Engineer to work closely with RD and Manufacturing Engineering in the development of Equipment/Fixtures and processes necessary to produce Stents/Delivery Systems in a lean manufacturing environment. Design, Implement and qualify new fixtures, equipment and methods, generate testing protocols and reports, and work with minimal direction


**Day in the life:**

Design and implement 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 and Quality Engineering, and Production Operations.

Lead the development of highly capable manufacturing processes for new products through frequent interaction with RD, Manufacturing Engineering, Quality Engineering, and Operations.

Lead the Development and coordinate the execution of process characterization and validation plans.

Ensure all Manufacturing Engineering elements of the PDP for new products meet the needs of each group.

May have supervisory responsibility for junior engineers technician staff.

Comply with applicable FDA and international regulatory laws/standards

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

Need to work with outside OEM Suppliers, internal/external machine shops and or other departments/groups

Other duties as assigned or required


**Must Have: Minimum Qualifications**

- Bachelor's Degree in Electrical Engineering, Mechanical Engineering or similar engineering discipline or related technical field

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


**Nice to Have**

Design and implement 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.

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

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)

Computer literate; word processing, spreadsheets,

Solidworks, AutoCad

Knowledge in materials associated with medical devices such as Metals (nitinol, cobalt chromium, platinum, stainless steel, aluminum, etc.). Polymers (nylons, polyethylene, polypropylene, PEEK, PTFE, FEP, etc.) and Composites.

Knowledge in Stent and Delivery System Manufacturing processes such as (laser cutting, laser welding (similar/dissimilar materials), heat setting, electropolishing, 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.

Proficiency with program languages such as (g-code, C++, VB etc.)


**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.

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Posted: 2019-08-23 Expires: 2020-01-31
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Principal Manufacturing Engineer

Medtronic
Irvine, CA 92617

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