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!
Job Summary:
We are seeking a highly skilled and detail-oriented Medical Injection Molding Process Engineer to lead the development, optimization, and validation of injection molding processes used to manufacture precision medical components. This role is responsible for ensuring robust, repeatable, and compliant manufacturing processes that meet regulatory requirements (ISO 13485) and support high-volume production in a cleanroom environment. The Process Engineer will play a key role in new product introductions, continuous improvement initiatives, and troubleshooting activities.
General Duties (includes but not limited to):
- Develop, optimize, and validate injection molding processes for new and existing medical products.
- Lead mold and material trials, establish robust process windows, and conduct Design of Experiments (DOE) to optimize quality and efficiency.
- Collaborate with R&D, tooling, quality, and manufacturing teams during product development and commercialization.
- Author and execute validation protocols (IQ, OQ, PQ) in compliance with ISO 13485 requirements.
- Troubleshoot molding and tooling issues; implement root cause analysis and corrective actions (CAPA).
- Evaluate and approve mold designs, materials, and process control plans to ensure manufacturability and scalability.
- Specify and support installation of new injection molding machines, robotics, and auxiliary equipment.
- Analyze process data using risk-based (e.g., PFMEA) and statistical methods (e.g., SPC, SixmaXL); maintain documentation of process settings and changes.
- Drive continuous improvement initiatives focused on yield, cycle time, scrap reduction, and cost savings.
- Train technicians and operators on molding best practices, process control, and cleanroom requirements.
- Ensure compliance with cleanroom protocols and current Good Manufacturing Practices (cGMP).
Education & Experience:
- Bachelor's degree in Plastics Engineering, Mechanical/Industrial Engineering, Biomedical Engineering, or related field.
- 3-7 years of experience in injection molding process development, with a focus on medical device manufacturing.
- Experience in a regulated cleanroom environment (ISO Class 7/8) and with medical-grade and engineering materials (e.g., PC, PA, ABS, Acrylic, PP).
- Deep knowledge of injection molding principles, mold design, and thermoplastic materials.
- Ability to learn and adhere to electronic Quality Management System (eQMS).
- Proficient in scientific injection molding techniques and DOE methodology.
- Familiarity with validation practices per ISO 13485 standards.
- Experience with injection molding equipment (e.g., Fanuc, JSW) and related software (RJG, SigmaXL, etc.).
- Strong analytical, troubleshooting, and project management skills.
- Excellent written and verbal communication; ability to write technical reports and validation documentation.
- Detail-oriented, quality-focused, and able to work independently or in cross-functional teams.
- Work performed in both office and ISO Class 7/8 cleanroom manufacturing environments.
- Occasional travel to suppliers or tooling vendors may be required.
- Use of personal protective equipment (PPE) and adherence to cleanroom protocols is mandatory.
- 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% invested 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.
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 prior 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.