Molding Engineer Supervisor

Description About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

The Molding Engineering Supervisor position is primarily responsible for leading and supervising the development, implementation, and optimization of injection molding processes and equipment for new and existing medical devices and component production lines. This individual will apply their knowledge of plastic and silicone materials and scientific molding principles to improve safety, quality, delivery, and cost while ensuring compliance with applicable medical device quality and regulatory requirements.

• Supervise, train, and mentor molding process engineers, process technicians, and tooling specialists.
• Lead design and implementation of injection molding processing and equipment solutions that improve safety, quality, delivery, and cost for new and existing molding production lines.
• Utilize indepth knowledge of injection molding processing and materials to develop and maintain mold tools, fixtures, and molding equipment to optimize productivity, maintainability and scalability.
• Apply scientific molding principles to define, characterize, and optimize molding processes, including mold tool qualifications, process characterization window studies, and molding process qualifications.
• Define, prepare, and implement engineering and production documentation, including equipment qualifications (IQ/OQ/PQ), process and work instructions, and technical reports.
• Troubleshoot injection molding equipment, molding processes, tooling issues, and molded part defects using scientific molding tools and data driven problem solving methods; develop corrective action plans with defined timelines and followthrough.
• Support process failure mode and effects analysis (pFMEA), risk assessments and mitigations, and continuous improvement initiatives related to molding operations.
• Collaborate with cross-functional engineering team, customers and suppliers to evaluate and influence product and process designs for manufacturability (DFM), quality, and cost reduction.
• Serve as a technical expert, from a molding perspective, during all phases of design and development - prototype builds, design verification, clinical builds, process validation and transfer to production.
• Provide technical guidance and mentoring to molding engineers, technicians and other associates on the team on injection molding processes, equipment operation, and process control.
• Track and communicate project status to internal and external stakeholders related to molding activities, including risks, issues, timelines, and deliverables.

• Associate's degree or Diplomain engineering (Plastics, Mechanical or another relevant field).
• 10+ years of experience working in a regulated manufacturing environment involving injection molding processes, tooling, and materials.
• Previous work in a medical device manufacturing environment (Class II/III) highly desired.
• Working knowledge of scientific molding methodologies, including root cause analysis, DOEs, process characterization, and robust process development.
• Demonstrated experience with mold qualifications, process validations, and medical device quality system requirements.
• Experience with leading and managing a team of engineers and technicians preferred; supervisory experience at minimum.
• Ability to train and support technicians and other engineering personnel on moldingrelated activities.
• Ability to read, interpret, and create technical drawings, specifications, and…