Process Engineer

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 has been a trusted supplier of fluid-control components for over 20 years. Our current senior management team has been with Injectech since the very beginning, bringing extensive knowledge of the medical device industry to every project.

Injectech is important to us! We want the best for our employees, not just at work, but through all aspects of their life. That is why we offer comprehensive benefits including health insurance, a 401(k) plan with up to 6% company match, and access to free financial advice about retirement, debt, and any future financial needs from a licensed Financial Advisor. We strongly believe that the only way for our company to be successful is to make sure our employees have healthcare, mental healthcare, retirement options and financial education available to them.

We work hard to create a culture that promotes open lines of communication, a flexible work-life balance, continuous improvement in every department, and a place where employees want to be every day. We strive to hire and retain the best people, because we know a company is only as good as its employees. We hope you will join our team as we continue to grow and improve!

This position will remain open until filled.

Location: On-site in Fort Collins, CO

Schedule & Hours: Mon-Fri, 7:00am-3:30pm

Essential Duties & Responsibilities

• Monitor and analyze injection molding processes to identify opportunities for optimization and improvement.
• Conduct process audits, collect data, and perform statistical analysis to assess process performance and variability.
• Investigate and troubleshoot molding defects, part quality issues, and process deviations using Root Cause Analysis (RCA) methodologies.
• Implement corrective and preventative actions to address process issues and prevent recurrence.
• Work closely with the Tooling Engineer and Maintenance Technician to ensure proper maintenance and upkeep of injection molds, machinery, and auxiliary equipment.
• Coordinate mold changes, equipment upgrades, and repairs to minimize downtime and optimize production efficiency.
• Lead or participate in continuous improvement projects aimed at enhancing process capabilities, reducing cycle times, and improving quality and consistency.
• Implement Lean Manufacturing principles and methodologies to streamline workflows, eliminate waste, and increase productivity.
• Maintain accurate documentation of process parameters, Standard Operating Procedures (SOPs), and validation protocols.
• Generate reports, analyze data trends, and present findings to management and stakeholders as needed.
• Collaborate with cross-functional teams, including engineers, technicians, and quality assurance.

Qualifications & Skills

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• 1+ years of experience in Injection Molding processes required, preferably in the medical device manufacturing industry.
• Knowledge of MS Office Programs such as Excel, Word, PowerPoint, etc.
• Familiar with ISO regulated environment; highly regulated industry experience such as medical device, automotive, or aerospace is preferred.
• Knowledge of MS Office Programs such as Excel, Word, PowerPoint, etc.
• Familiar with ISO regulated environment; highly regulated industry experience such as medical device, automotive, or aerospace is preferred.
• Knowledge of SOPs, Work Instructions, and ISO 13485 standards preferred.
• Actively performs and understands Good Documentation Practices (GDP).
• Knowledge of Quality Management Systems (QMS) and regulatory standards such as ISO 13485 and FDA 21 CFR Part 820.
• Knowledge of CAD/CAM software such as SolidWorks, AutoCAD, or Pro/ENGINEER for designing and modeling injection molds and tooling components.
• Proven track record of optimizing injection molding processes, troubleshooting issues and driving continuous improvement initiatives.
• Knowledge of injection molding principles including mold design, material selection, processing parameters, and tooling considerations.
• Proficiency in process optimization techniques, Design of Experiments (DOE), and statistical analysis to improve product quality, cycle times, and yields.
• Familiarity with scientific molding principles and advanced molding technologies (e.g., gas-assisted molding, multi-component molding)
• Knowledge of regulatory requirements and standards governing medical device manufacturing, including FDA regulations and ISO 13485 quality management systems.
• Experience in implementing and maintaining compliant manufacturing processes and documentation.
• Strong analytical and problem‑solving skills to diagnose root causes of molding defects, process variations, and non‑conformances.
• Ability to develop and implement effective solutions to address process issues and improve overall process capability and efficiency.
• Ability to communicate technical concepts and recommendations clearly and effectively to stakeholders at various levels of the organization.
• RJG Master Molder Certification, Society of Plastics Engineers (SPE) Injection Molding Certificate Program, Six Sigma, Certified Injection Molding Professional (CIMP), or other related certifications preferred.

Work Environment & Physical Demands

• Ability to sit, stand, and walk for extended periods throughout the workday (up to 8 hours).
• Ability to communicate verbally, hear clearly, and maintain corrected vision sufficient for reading, writing, inspecting equipment, and working with detailed components.
• Physical agility to bend, kneel, reach, and perform hands‑on equipment troubleshooting and maintenance tasks.
• Precise hand‑eye coordination for handling tools, small components, and machinery safely and accurately.
• Ability to lift and/or move up to 80 lbs., with or without reasonable accommodation.
• Comfortable working in manufacturing environments with varying temperatures, noise levels, and exposure to industrial materials.
• Occasional travel to suppliers or tooling vendors may be required.

Benefits

• 401(K) Retirement Plan
• Profit Share Program

• Medical, Dental, Vision, Life & AD&D Insurance, Short Term Disability (STD), Long Term Disability (LTD), Supplemental Insurance Plans, and Employee Assistance Program (EAP)
• Sick Time, Vacation Time, Holiday Pay, Volunteer Time Off (VTO), and Bereavement

Drug Testing Policy

Injectech is committed to maintaining a safe and productive workplace. As part of this commitment, all potential employees must pass a drug screening as a condition of employment. The drug test is a 5-panel screening and must be completed to your start date.

Injectech is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law. We are committed to creating a diverse and inclusive workplace and encourage candidates from all backgrounds to apply.