Sr. Process Molding Engineer

Description

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 Sr. Process Molding Engineer position is primarily responsible for the design, development, implementation, and optimization of injection molding processes and equipment for new and existing medical device production lines. This role applies advanced silicone, plastics, and scientific molding principles to improve safety, quality, delivery, and cost while ensuring compliance with applicable medical device quality and regulatory requirements. The position works cross‑functionally within a project engineering environment and supports process development, qualification, validation, and manufacturing transfer activities.

• Design, detail, and implement injection molding process and equipment solutions that improve safety, quality, delivery, and cost for new and existing molding production lines.
• Utilize in‑depth knowledge of injection molding, resins, silicones, and plastics processing to develop molds, tooling, fixtures, and auxiliary equipment that optimize productivity, maintainability, and total cost of ownership.
• 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 machines, 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 follow‑through.
• Support process failure mode and effects analysis (pFMEA), risk assessments, and continuous improvement initiatives related to molding operations.
• Collaborate with Development Engineers, Tool Makers, Team Leaders, Technicians, Customers, and Suppliers to evaluate and influence product and process designs for manufacturability, quality, and cost reduction.
• Support feasibility builds, prototype tooling, equipment selection, and process development activities for new products.
• Provide technical support during design verification, clinical builds, training builds, process validation, and manufacturing transfer to production.
• Provide technical guidance and mentoring to technicians and associates on injection molding processes, equipment operation, and process control.
• Track and communicate project status related to molding activities, including risks, issues, timelines, and deliverables.

• Bachelor's degree in Engineering required (Mechanical, Manufacturing, or related STEM discipline preferred) and 5+ years of relevant molding experience.
• Demonstrated experience with injection molding processes, tooling, and materials, preferably in a regulated medical device manufacturing environment (Class II and/or Class III).
• Working knowledge of scientific molding methodologies, including DOE, process characterization, and robust process development.
• Experience with mold qualifications, process validations, and medical device quality system requirements.
• Ability to read, interpret, and create technical drawings, blueprints, specifications, and process documentation.
• Strong analytical, troubleshooting, and problem‑solving skills.
• Demonstrated ability to work effectively in cross‑functional teams and communicate technical information clearly.
• Proficiency…