We have an exciting new position at our growing Greensboro, NC Plant for a Process Engineer! In this role you will establish, validate, and maintain high-precision injection molding processes for drug delivery, pharmaceutical packaging, and medical device components. Operating within our ISO 13485 and ISO 9001 certified quality systems, this role supports the optimization of high-volume production in white room and clean room environments.
If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you.
Responsibilities:- Develop and optimize processes by establishing, validating, and maintaining scientific molding processes for injection molded components.
- Ensure validation and compliance with quality protocols for molds, presses, and auxiliary equipment. Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ).
- Perform root cause analysis troubleshooting molding defects.
- Drive continuous improvement and lean manufacturing initiative to meet and exceed operational objectives and goals.
- Collaborate with toolmakers to evaluate new molds, modifications, and repair requirements
- Write standard operating procedures, validation reports, and technical manufacturing specifications.
- Ensure compliance with applicable FDA and ISO standards.
- Develop and deliver new injection molding capabilities utilizing designed experiment. methodology (DOE) for process window characterization, parameter selection, and rigorous process qualification.
- Utilize Lean Thinking, Six Sigma and 5S concepts when creating new or improving existing processes.
- Establish maintenance requirements for new equipment.
- Evaluate the impact of new processes introductions on manufacturing environments.
- Assess and implement process changes driven by mold modifications, resin variances, or molding quality issues.
- Perform process risk analysis through PFMEA activities to support new or existing processes.
- Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes.
- Support quality audits of manufacturing processes.
- Develop molding cycle times, cavitation expectations, and resin yield rates for customer quotations in response to inquiries while working with Tooling, Engineering, Purchasing, and Customer Service to obtain needed information.
- Lead project activities through the management of budgets, resources, timelines, and deliverables.
- Communicate effectively with customers and vendors in a technical capacity.
- Travel up to 5% may be needed.
Physical Requirements:- Must wear required Personal Protective Equipment (PPE)
- Requires excellent close vision and color vision.
- Up to 80% walking or standing.
- Ability to lift 35-50lbs on a regular basis.
- Mobility and agility required to crawl under equipment, reach over equipment, and climb ladders.
- Dexterity to handle small components, use precision hand tools, and safely navigate around hot surfaces.
- Working on non-traditional surfaces is required e.g., lift, crane, ladder, etc.
Skills/Qualifications:- Minimum 5 years of hands-on injection molding experience, with demonstrated knowledge of molding processes, tooling, materials, and process optimization.
- Bachelor's degree or equivalent experience in Engineering or related technical field preferred; equivalent combination of education, technical training, and relevant experience will be considered.
- Demonstrated ability to troubleshoot molding processes, identify root causes, and implement process improvements.
- Experience in a medical white room or certified ISO Class 7/8 cleanroom environment highly preferred.
- Proficient in scientific molding principles, RJG Master molder certification preferred.
- Excellent cross functional communication skills and technical writing skills.
- Methodical, highly detailed, and able to write and adhere to manufacturing protocols.
Personal Attributes:- Meets Gilero core values of Collaboration, Innovation, Integrity, and Excellence.
- Works well with others and can work independently.
- Comfortable and productive in a fast-paced, entrepreneurial environment.
- Attention to detail and ability to operate in a highly regulated, quality centric environment.
- Commitment to excellence and quality service to external and internal customers.
- Commitment to established policies and procedures, while contributing to continuous improvements.
Eligibility to Work:- Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
- Gilero does not offer sponsorship for employment authorizations (work visas).
- We are an E-Verify employer and confirm work authorization for all new hires.
You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.
