23 days old

Process Engineer

Kelly Services
Dublin, CA 94568
Process Engineer

Dublin, CA

Up to 60 an hour

1 year contract

Summary: Engineering contractor role. Manages and coordinates projects activities that involve new product development and commercial product support. Aspects of the role include execution of product and process improvements, manufacturing process transfers, production scale-up, process validation, launch support, and on market product technical support.

Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

Member of cross-functional development teams to assist in the implementation of process and product requirements.

Coordinate and execute activities for new product technology transfer to commercial manufacturing equipment qualification, supplier component qualification, and process validation for commercial manufacturing process.

Oversee new product process validation at commercial manufacturing sites.

Coordinate and facilitate the transfer of product to manufacturing.

Technical interface with contract manufacturers, vendors, and suppliers.

Provide technical support to currently market products.

Support launch of new products and ensure product is manufacturing ready for commercial distribution.

Assure that manufacturing transfers and new product introductions meet Regulatory requirements such as FDA cGMP and ISO 13485.

Support product labeling updates and implementation.


Knowledge and Skills:

Knowledge of:

Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory and safety compliance requirements and guidelines.

Design Control Process (ISO 13485 and FDA QSR 820).

Device manufacturing process design/DFM and scale-up including equipment, testing, assembly operations and support systems.

Injection molding and plastics extrusion

Process Validation (process and equipment)

Skill in:

Analyzing, troubleshooting, and identifying problems, and recommending and implementing methods, procedures and/or techniques for resolution. Problem solving techniques.

Experimental design

Statistical techniques

Quality by Design (QbD)

Communicating clearly and concisely, both orally and in writing.

Establishing and maintaining cooperative working relationships with those contacted in the course of work.

Performing all necessary engineering project functions efficiently and in a timely manner.

Handles a diverse workload of assignments, covering several disciplines of engineering; maintains proper priority of multiple assignments.

Complies with all Company policies and procedures, including safety rules and regulations.


Bachelor's degree in Engineering or Science from an accredited college or university in addition to

1 year to 5 of engineering work experience, preferably in a medical device development and manufacturing environment, and hands-on or technical training in the field of design or manufacturing engineering.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-04-29 Expires: 2022-05-30

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Process Engineer

Kelly Services
Dublin, CA 94568

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