Principal, Molding & Tooling Engineering

About the role

The Principal, Molding & Tooling Engineering (Science/Tech/Engineering Path) leads strategic and technical initiatives related to injection molding processes, mold/tooling design, and manufacturing optimization. This role serves as a subject matter expert (SME) for molding and tooling, driving innovation, improving throughput, and supporting New Product Introduction (NPI) and continuous improvement across global operations.

Responsibilities

• Design and develop precision mold tooling and optimize injection molding processes for efficiency, reliability, and part quality
• Lead and approve improvements and validations for injection molds, tooling support systems, and molding equipment
• Provide technical guidance during mold maintenance, qualification, and machine/equipment troubleshooting
• Investigate process issues, and implement advanced improvements in tooling design and manufacturing techniques
• Define and optimize molding processes through capability studies, DOE, root cause analysis, and validation activities (IQ/OQ/PQ)
• Oversee molding trials, process documentation, and assessments of raw material impacts on molding performance
• Collaborate with cross-functional partners to reduce defects, enhance mold performance, and elevate production throughput
• Scout and evaluate advanced tooling technologies and auxiliary equipment to drive safety, efficiency, and cost savings
• Recommend capital investments, support tooling standardization, and write capital justifications
• Support New Product Introduction (NPI) from concept through production ramp-up, managing timelines, risks, and cost targets
• Partner with suppliers, contract manufacturers, and global teams to ensure robust solutions across the product lifecycle
• Mentor junior engineers and technicians on best practices in molding, tooling, and process development
• Ensure all tooling designs and molding processes meet regulatory, safety, and quality requirements for medical devices
• Maintain documentation, change control, and quality compliance across internal and external systems
• Uphold GxP requirements by following SOPs, maintaining accurate documentation, and ensuring rigorous quality control
• Contribute to a culture of continuous improvement and operational excellence

Requirements

Specifics Include:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• Five (5) Years of Relevant Experience
• Work Hours: Exempt: 40 hours per week: Monday – Friday, 8:00 AM EST – 5:00 PM EST
• Travel Requirements: Up to 10%
• Location: Onsite
• Relocation is Available
• Sponsorship is Not Available

Preferred Qualifications/Skills/Experience

• Degree in Engineering (Plastics or Mechanical Engineering strongly preferred but open to other disciplines)
• Strong understanding of scientific molding principles
• Proven experience troubleshooting and optimizing injection molding processes and equipment
• Experience performing molding process validation and qualification (IQ/OQ/PQ)
• Hands-on experience with hot runner systems and hot runner troubleshooting
• Experience troubleshooting automation, including end-of-arm (EOA) tooling
• Experience with process monitoring systems
• Experience with contact and non-contact dimensional inspection
• Industry experience in medical device manufacturing or other regulated environments