Process Engineering Manager Position Summary Reporting to the Director of Operations, the Process Engineering Manager leads the Process Engineering team in developing, validating, and optimizing manufacturing processes for medical products, with a strong focus on Liquid Silicone Rubber (LSR) and other molding technologies. This role drives continuous improvement through scientific molding, ensures compliance with

ISO 13485

requirements, and partners with Manufacturing, Quality, Application Engineering, and Sales to deliver safe, efficient, and scalable production. The Process Engineering Manager also oversees process qualification at the corporate facility and supports successful technology transfer to other manufacturing sites. Key Responsibilities Lead and develop the Process Engineering team while promoting a culture of Safety, Quality, Delivery, and Cost (SQDC). Apply scientific molding principles to develop, validate, and improve manufacturing processes, including

IQ/OQ/PQ

activities. Ensure process documentation and validation comply with ISO 13485 and applicable customer and regulatory requirements. Manage process qualification and technology transfer to other facilities through standardized work, training, and ongoing support. Develop engineering specifications, process documentation, and manufacturing standards that meet quality and performance objectives. Prepare cost estimates and tooling quotations while collaborating with Manufacturing, Sales, Tooling, Quality, and Materials teams. Provide technical support to resolve manufacturing and customer process issues. Mentor and develop Process Engineers while supporting Process Technician training with Manufacturing leadership. Maintain accurate documentation, evaluate equipment and vendors, and identify opportunities to improve safety, quality, delivery, and cost through continuous improvement initiatives. Qualifications Bachelor's degree in Engineering or a related field preferred, or equivalent experience in scientific process development. RJG Master Molder I or II certification preferred, or equivalent scientific molding certification (such as Paulson ProMolder). Strong knowledge of Statistical Process Control (SPC) and Design of Experiments (DOE). Proven leadership skills with the ability to influence, mentor, and develop teams. Experience with IQMS or a comparable ERP/MRP system and strong document control practices. Excellent project management, organizational, and communication skills with the ability to manage multiple priorities.

Pay:

$125,000.00 - $155,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Retirement plan Tuition reimbursement Vision insurance

Education:

Bachelor's (Preferred)

Experience:

plastic or rubber molding: 5 years (Preferred)

Work Location:

In person