Manufacturing Engineer

Millenniumsoft•Tempe, AZ

48d•Onsite

About The Position

This role supports the facility's Quality System and tactical plans. The Manufacturing Engineer will design, develop, qualify, and validate manufacturing processes and tooling/equipment. Key responsibilities include driving continuous improvement, enhancing safety, and reducing costs. The position involves participating in cross-functional project teams, executing individual project tasks, and performing mechanical/electrical testing and gauge R&R studies. Data analysis using statistical methods (e.g., process capability, Design of Experiments) is required. The role also includes troubleshooting processes, equipment, and quality systems, developing and implementing corrective and preventive actions, and providing sound engineering judgment. Qualifying and validating new materials and suppliers, training manufacturing employees on specifications and processes, and authoring CRs, protocols, technical reports, and AFEs are also essential functions. The Manufacturing Engineer will serve as a technical interface with manufacturing teams and perform other related duties as assigned.

Requirements

Ability to translate technical documents to manufacturing operators.
Ability to be flexible and deal with changing priorities.
Demonstrates strong communication skills across all levels of the organization, both internal and external.
Take initiative in learning new technologies and materials.
Associate Degree in engineering, scientific or technical discipline or 3 years or more of work experience in medical device manufacturing.

Nice To Haves

Customer focus, innovative, results oriented.
Experience in a regulated environment.
Ability to solve problems and conflicts, work well with others and demonstrate team work.
Demonstrates a solid work ethic and positive demeanor/attitude.

Responsibilities

Support facility’s Quality System and tactical plans.
Design, develop, qualify, and validate manufacturing processes and tooling/equipment.
Drive continuous improvement, improved safety and cost reductions.
Participate in cross functional project teams and execute individual project tasks.
Perform mechanical/electrical testing and gauge R&R studies.
Statistically analyze data (e.g., process capability, Design of Experiments).
Trouble-shoot processes, equipment and quality systems and develop/implement corrective and preventive actions.
Provide sound engineering judgment and decisions.
Qualify and validate new material and suppliers.
Effectively train manufacturing employees on specifications and processes.
Author CRs, protocols, technical reports and AFEs.
Technical interface with manufacturing teams.
Perform other related duties as assigned.