Process Technician Lead

Injectech•Fort Collins, CO

8h•Onsite

About The Position

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 pay 100% of the employee’s share of health insurance cost and match up to 6% for our 401k plan and provide 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! General Duties (includes but not limited to): Set up and operate injection molding machines, robotics, and auxiliary equipment in accordance with established procedures and medical industry standards. Perform mold installations, machine start-ups, and shutdowns following cleanroom protocols. Support as needed f or handling, transporting, and loading of raw material(s) for injection molding. Support as needed, set up, install, and remove plastic injection molds on machines according to the production schedule and setup sheets. Monitor and fine-tune process parameters to ensure consistent product quality and optimal cycle times. Troubleshoot and resolve process deviations, part defects, and equipment malfunctions. Work closely with quality control, engineering, and maintenance teams to ensure part conformance and process stability. Maintain detailed records of process settings, mold history, deviations, and corrective actions per ISO 13485 requirements. Adhere to cleanroom gowning procedures and maintain a sterile work environment. Perform minor maintenance on molding machines and tooling; coordinate with maintenance for complex repairs. Participate in validations, DOE studies, and continuous improvement projects. Support training of operators and junior technicians in cleanroom practices and molding procedures. Lead Responsibilities: Assist management with new team member training. Use leadership to guide and direct the team towards specific goals. Focus on day-to-day operations and guiding the team towards specific goals. Provide mentorship, coaching, training, and support to team members. Contribute and work alongside team members while also coordinating and delegating tasks. Ensure that team members understand their toles, tasks, and expectations. Communicate with upper management to report progress and discuss challenges. Monitor team workflow to identify and address task-related issues that may impact productivity. Give feedback of team members and department flow to upper management. Encourage team members to follow work safety protocol and cleanliness throughout the department.

Requirements

High school diploma or GED required; technical certification or associate degree in plastics, engineering, or manufacturing preferred.
2–5 years of experience in medical injection molding, with hands-on experience in a regulated cleanroom environment.
Understanding of c GMP and ISO 13485 compliance.
Proficient in reading technical drawings and using precision measuring instruments.
Strong problem-solving, communication, and documentation skills.
W ork independently and collaboratively within controlled quality standards.
Must adhere to cleanroom protocols including gowning and hygiene requirements.
Work performed in a temperature-controlled ISO Class 7/8 cleanroom.
Frequent standing, walking, bending, and lifting (up to 50 lbs).
Use of personal protective equipment (PPE) is required.

Nice To Haves

Experience with IQ/OQ/PQ validation processes preferred.
Formal processing certification, SIM preferred.
Understanding of Six Sigma and Lean principles preferred.
In-depth knowledge of injection molding machines (e.g., Fanuc, JSW, etc.).
Familiarity with medical-grade and engineering materials (e.g., PC, ABS, PA, PP, Acrylic).

Responsibilities

Set up and operate injection molding machines, robotics, and auxiliary equipment in accordance with established procedures and medical industry standards.
Perform mold installations, machine start-ups, and shutdowns following cleanroom protocols.
Support as needed f or handling, transporting, and loading of raw material(s) for injection molding.
Support as needed, set up, install, and remove plastic injection molds on machines according to the production schedule and setup sheets.
Monitor and fine-tune process parameters to ensure consistent product quality and optimal cycle times.
Troubleshoot and resolve process deviations, part defects, and equipment malfunctions.
Work closely with quality control, engineering, and maintenance teams to ensure part conformance and process stability.
Maintain detailed records of process settings, mold history, deviations, and corrective actions per ISO 13485 requirements.
Adhere to cleanroom gowning procedures and maintain a sterile work environment.
Perform minor maintenance on molding machines and tooling; coordinate with maintenance for complex repairs.
Participate in validations, DOE studies, and continuous improvement projects.
Support training of operators and junior technicians in cleanroom practices and molding procedures.
Assist management with new team member training.
Use leadership to guide and direct the team towards specific goals.
Focus on day-to-day operations and guiding the team towards specific goals.
Provide mentorship, coaching, training, and support to team members.
Contribute and work alongside team members while also coordinating and delegating tasks.
Ensure that team members understand their toles, tasks, and expectations.
Communicate with upper management to report progress and discuss challenges.
Monitor team workflow to identify and address task-related issues that may impact productivity.
Give feedback of team members and department flow to upper management.
Encourage team members to follow work safety protocol and cleanliness throughout the department.

Benefits

401K Retirement Plan- Eligible to contribute starting the first of the month, 2 months after your hire date. Injectech matches up to 6% of your salary. Contributions are 100% vested immediately. Both Roth and Traditional options are available.
Health Insurance- Coverage begins the first of the month after 30 days of employment. Injectech covers 100% of the employees' premium. You may add a spouse, domestic partner, or dependents at your own cost via pre-tax payroll deductions.
Dental, Vision and Supplemental Insurance Plans- Offered at a group discount rate for employees, spouses, domestic partners, and dependents.
Employee Assistance Program- Available to all employees and their family members at no cost.
Sick Time- Accrues at 1 hour for every 30 hours worked, up to 48 hours per year.
Paid Time Off (PTO) First 36 months: 6.66 hours per month (up to 80 hours per year). After 36 months: 8 hours per month (up to 96 hours per year). Accrual rates continue to increase with tenure.
Holiday Pay- 10 paid holidays per year.
Voluntary Paid Time Off (VTO)- Up to 20 hours per year to volunteer at any 501(c)(3) nonprofit of your choice.
Life and AD&D Insurance- Injectech provides a $50,000 policy at no cost to employees. Additional coverage is available for purchase.
Profit Share Program- Eligible to participate the month following 6 full months of employment.