Position Summary:

A shared engineering position supporting both the Molding Engineer and the Manufacturing Engineer. The employee works under whichever of the two owns the current assignment and moves between molding and manufacturing work as production demand requires. The position is intended for an engineer early in their career who will develop under two experienced engineers.

Position Details:

Location:

On-site, Orem, Utah.

Schedule:

Full-time.

Compensation:

$82,000 to $97,000 annually

Benefits:

Paid time off.

Responsibilities:

• Support injection molding and manufacturing engineering activities as assigned by the Molding Engineer or the Manufacturing Engineer.
• Set up, program, and adjust injection molding machines under the direction of the Molding Engineer.
• Establish, document, and maintain process parameters for molding and assembly operations.
• Troubleshoot molding defects, machine malfunctions, and material inconsistencies; escalate issues that exceed current experience level.
• Support root cause analysis for process failures and carry out assigned corrective actions.
• Develop, validate, and train on document manufacturing processes, work instructions, tooling, and fixtures.
• Author and execute

IQ/OQ/PQ

protocols and write the associated reports.

• Perform in-process inspections and tests on molded and assembled parts; verify that product meets drawing and specification.
• Support preventive maintenance and machine readiness to minimize downtime.
• Collect and summarize production data (scrap, cycle time, yield) and report findings.
• Comply with design control, document control, and change control requirements; support Device Master Record and Design History File documentation.
• Complete and maintain assigned quality system training records per 21 CFR 820.25.
• Understand the Company's Quality Policy, ensuring that it is understood and implemented where appropriate.

Qualification Requirements:

Required:

a B.S. degree in Mechanical, Manufacturing, Plastics, Industrial, or Biomedical Engineering, or a closely related engineering or scientific field.

• 0 to 3 years of experience. Internship, co-op, or academic project work is acceptable in place of industry experience.
• Working knowledge of injection molding principles, machinery, and thermoplastic material behavior.
• Ability to read and interpret engineering drawings, GD&T, and specifications.
• Familiarity with mechanical systems and comfort with hands-on machine work.
• Analytical skills for troubleshooting and root cause analysis.
• Working knowledge of quality control methods, inspection techniques, and measurement tools.
• Computer literacy, including CAD and spreadsheet work.
• Good verbal and written communication skills; able to write clear procedures and reports.
• Willingness to learn medical device regulatory requirements (21 CFR 820, ISO 13485). Prior exposure is encouraged and considered favorably, but is not required.
• Ability to take direction from two engineers and to move between assignments without loss of continuity.

Preferred:

exposure to lean manufacturing or continuous improvement methods.

Resources:

• Molding Engineer and Manufacturing Engineer for technical direction, assignment, and mentoring
• COO for priority decisions and escalation
• Corporate Officers and Managers
• Quality Manual and controlled procedures
• Equipment manuals, material data sheets, and tooling drawings
• Appropriate seminars, training, and courses as needed

Pay:

$82,000.00 - $97,000.00 per year

Benefits:

Flexible schedule Paid time off

Work Location:

In person