Principal Injection Molding Tooling Architect

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A day in this role

As the Principal Injection Molding Tooling Architect within our Engineering organization, you are the go-to expert for molding and tooling across our global operations. Your morning might begin by reviewing capability studies and DOE outputs from a Husky cell, then walking the floor to assess tool performance and automation hand-offs. Midday you may lead an IQ OQ PQ validation, consult on hot runner troubleshooting, and finalize a capital justification for a next-generation auxiliary system.

You will partner with suppliers and contract manufacturers on a new product transfer, mentor a junior engineer on root cause methods, and wrap up by updating change control records in alignment with GxP and medical device quality requirements.

What you will own Design and develop precision mold tooling and optimize injection molding processes for efficiency, reliability, and superior part quality

Lead and approve improvements and validations for injection molds, tooling support systems, and molding equipment

Provide expert guidance for mold maintenance and qualification, and troubleshoot molding machines and related equipment

Investigate process excursions and implement advanced enhancements in tooling design and manufacturing methods

Define and optimize molding processes through capability studies, DOE, root cause analysis, and validation activities including IQ OQ PQOversee molding trials, author process documentation, and evaluate how raw material variation affects molding performance

Collaborate with cross functional teams to lower defect rates, improve mold performance, and raise production throughput

Scout and assess advanced tooling technologies and auxiliary equipment to improve safety, efficiency, and cost Recommend capital investments, support tooling standardization, and write capital justifications

Support New Product Introduction from concept through 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 in molding, tooling, and process development best practices

Ensure tooling designs and molding processes meet regulatory, safety, and quality expectations for medical devices

Maintain documentation, change control, and quality compliance across internal and external systems

Uphold GxP by following SOPs, keeping accurate documentation, and ensuring rigorous quality control

Contribute to a culture of continuous improvement and operational excellence

What you will bring

Bachelor’s Degree or equivalent directly related experience: high school plus 13 years, Associate’s plus 9 years, M.S. plus 2 years, or PhD plus 0 years

Ability to read, write, understand, and communicate fluently in English5 years of relevant experience

Work hours:

Exempt, 40 hours per week, Monday – Friday, 8:00 AM EST – 5:00 PM ESTTravel requirements: up to 10 percent

Location:

onsite

Relocation is available

Sponsorship is not available

Preferred qualifications

Degree in Engineering;
Plastics or Mechanical strongly preferred, other disciplines welcome

Deep knowledge of scientific molding principles

Proven track record troubleshooting and optimizing injection molding processes and equipment

Experience executing molding process validation and qualification IQ OQ PQHands on familiarity with hot runner systems and hot runner troubleshooting

Experience…