Process Engineer

Pacific International has been retained by a leading medical devices manufacturer who is looking to add a strong engineering professional to a critical plant in the Greater Salt-Lake area.

Recently they have taken on a new major client which has significantly increased the production volume for the facility.

This engineer will need to have prior experience in extrusion. He / she will be seen as a vital member of the site who can drive change, creates and implements new products / processes, improves overall productivity.

Responsibilities :

• Develop and implement new tooling, process improvements, new product process development, and cost / value improvement projects.
• Plan and coordinate the selection, procurement, installation, start-up, and qualification of new capital equipment, tooling, and fixtures for medical device manufacturing IQ / OQ.
• Perform cost improvement projects and quality improvement projects to support manufacturing goals that positively impact and reduce COGS.
• Implement and modify manufacturing task documents in coordination with process improvements and new equipment installations (change request).
• Develop and drive project plans by identifying tasks, resource requirements, time lines, and Cap Ex and expense budgets.
• Participate in the selection of Extrusion Equipment and tooling vendors.
• Develop equipment specifications from process and product specification.
• Ensure project completion on-time and within budget by tracking all project activities and providing management reports showing task status on requests.
• Provide equipment vendors with all documentation and sample components required to design, fabricate, troubleshoot, and accept equipment.
• Develop statistically valid equipment acceptance and installation protocols in conjunction with the manufacturing department personnel and Quality Assurance.
• Ensure all test methods specified in acceptance or installation protocols are properly defined and have acceptable measurement systems.
• Perform equipment acceptance testing and the results.
• Assist in installation and perform validation of new equipment.
• Determine the training for all personnel associated with the operation of the new equipment and provide those training materials.
• Comply with all local, state, federal, and SPG safety regulations, policies, and procedures (SPG safety absolutes).
• Comply with all quality policies, procedures, and practices through consistent application of sound quality assurance principles outlined in the site quality manual and ISO13485 : 2016 requirements.

Qualifications and Experience :

• BA or BS degree in Mechanical, Chemical, or Material Science preferred.
• Hands on attitude with a focus on supporting the production floor.
• Strong understanding of plastic materials and plastics extrusion processing.
• Excellent interpersonal and communication skills. Must be able to work with employees at all levels.
• Strong documentation skills with ISO 13485 knowledge preferred.
• 5 to 10 years of medical device manufacturing and extrusion / molding experience
• Computer proficient : Microsoft Office, CAD software, Minitab.
• CNC fabrication and machining process experience beneficial but not required.
• Understanding of plastic materials and ability to research materials.
• Understand customer requirements and application.
• Six Sigma Greenbelt or equivalent certification beneficial but not required.

Diversity statement :

At Pacific International, diversity, equity, and inclusion are at the core of who we are and what we do. Our commitment to these values is unwavering and we proudly champion diversity on behalf of our clients in every Executive Search mandate we undertake.

Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

In pursuit of these objectives, we actively encourage applications from individuals of all backgrounds and identities.