Injection Molding Process Engineer (Medical Devices)

Jobless; Fort Collins (CO); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

401(K) Retirement Plan

Profit Share Program

Medical, Dental, Vision, Life & AD&D

Job summary

Injectech, LLC is seeking a qualified professional to monitor and optimize its injection molding processes in Fort Collins, CO. The role emphasizes process audits, data collection, RCA troubleshooting, and CAPA implementation to improve quality and throughput.

The successful candidate will collaborate with Tooling Engineers and Maintenance Technicians, apply Lean methods, and maintain GMP-style documentation and SOPs in a regulated environment.

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related field.
• 1+ years of Injection Molding experience; medical device industry preferred.
• Experience with ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Monitor and analyze injection molding processes to identify optimization opportunities.
• Conduct process audits and statistical analysis to assess performance.
• Investigate and troubleshoot molding defects using Root Cause Analysis.
• Implement CAPA to address process issues and prevent recurrence.
• Work with Tooling Engineer and Maintenance Technician on molds and equipment.
• Lead continuous improvement projects to improve capabilities and efficiency.
• Apply Lean Manufacturing to reduce waste and increase productivity.
• Maintain documentation of SOPs and validation protocols.
• Generate reports and present findings to management.
• Collaborate with cross-functional teams including QA.

Skills

Injection molding

DOE

Statistical analysis

Root Cause Analysis (RCA)

Process optimization

CAD/CAM (SolidWorks/AutoCAD/Proe)

QMS / FDA 21 CFR Part 820 knowledge

GDP understanding

Education

Bachelor's degree in Mechanical/Manufacturing Engineering or related field

Tools

SolidWorks

AutoCAD

Pro/ENGINEER

Job description

Injectech, LLC is seeking a qualified professional to monitor and optimize its injection molding processes in Fort Collins, CO. The role emphasizes process audits, data collection, RCA troubleshooting, and CAPA implementation to improve quality and throughput.

The successful candidate will collaborate with Tooling Engineers and Maintenance Technicians, apply Lean methods, and maintain GMP-style documentation and SOPs in a regulated environment.