Process Engineer II - Irvine, CA (Onsite)

Job Posted 7/2/2023
Irvine, CA
United States
Category Wind Jobs
Job Description
**Careers that Change Lives**

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. Here’s where you come in!

We are seeking a hands-on Process Development Engineer II to work closely with R&D, Operations and Quality in the development of processes necessary to produce new Neurovascular Catheter products 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.

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned.

+ 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 equipment and 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 Have: Minimum Requirements**

+ Bachelor’s Degree in Mechanical, Material or Biomedical Engineering with 2+ years of work experience developing products and/or manufacturing processes in medical device industry

+ OR Advanced Degree in Mechanical, Material or Biomedical Engineering with 0 years of work experience developing products and/or manufacturing processes in medical device industry

**Nice to Have**

+ Knowledge of SolidWorks and engineering statistics

+ Knowledge of processing materials associated with medical devices such as Polymers (nylons, polyethylene, polypropylene, PEEK, PTFE, FEP, etc.), and Metals (nitinol, platinum, stainless steel, etc.).

+ Hands-on experience with processes associated with medical manufacturing such as shrinking (reflow), laser bonding, laser welding, thermal bonding, adhesive bonding, braiding, coil winding, hydrophilic coating, plasma treatment, cleaning processes, crimping, etc.

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

+ Experience working with outside OEM Suppliers in component development, and selection of equipment and processes.

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

+ 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.

Physical Job Requirements

The physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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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.

United States