Process Engineer

Job Title

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.

Our employees are 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!

Location:

On-site in Fort Collins, CO

Schedule &

Hours:

Mon-Fri, 7:00am-3:30pm

• 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.

• 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 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 Solid Works, 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…