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Senior Process Engineer- New Product Introduction (NPI)

Irvine, CA 92604
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Senior Process Engineer- New Product Introduction (NPI)


Irvine, California, United States

Requisition #:


Post Date:

Mar 24, 2020

**Senior Process Engineer- New Product Introduction (NPI)**

**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 Senior Process Engineer to work closely with RD, Operations and Quality in the development of new processes necessary to produce Catheters/Delivery Systems/Stents for a lean manufacturing environment. Manage development builds, develop new manufacturing processes, implement and qualify production equipment and methods, generate testing protocols and reports, and work with minimal direction for NPI.

**Day in the life:**

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.

Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling for New Product Introductions.

Design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.

Incorporate inspection and test requirements into the production plan.

Provides guidance to New Product Project Team(s) regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

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

Develop and coordinate the execution of Process Characterization(s) and Validation(s).

Work with outside OEM Suppliers

Comply with applicable FDA and international regulatory laws/standards

Other duties as assigned or required

**Must Have: Minimum Qualifications**

- Bachelors degree in Manufacturing, Mechanical, Electrical, Materials, Biomedical Engineering, or related technical field

- 4+ years of experience with Bachelors Degree OR 2+ years of experience with an Advanced Degree

**Nice to Have**

4+ years of experience in the Medical Device Industry

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.

Application of Lean Methodologies

Development of manufacturing documentation (MP, IP, BOM)

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

Participation on project teams tasked with new product development and the successful transfer into manufacturing.

Good verbal and written communication skills.

Computer literate; word processing, spreadsheets,

Solid works, AutoCad

Knowledge of materials associated with medical devices such as polymers (nylons, polyethylene, polypropylene, PEEK, Pebax, PTFE, FEP, polycarbonate, etc.) metals (stainless steel, aluminum, nitinol, platinum etc.), ceramic, fiber, composites, etc.

Knowledge of processes associated with medical manufacturing such as shrinking (reflow), RF welding, laser bonding, laser welding, thermal bonding, adhesive bonding, braiding, coil winding, insert molding, hydrophilic coating, plasma treatment, cleaning processes, cutting/skiving/slitting, crimping, etc.

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

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

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

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.


Posted: 2020-03-26 Expires: 2020-05-03
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Senior Process Engineer- New Product Introduction (NPI)

Irvine, CA 92604

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