We are a leading medical device manufacturer specializing in precision plastic injection molding. Our mission is to deliver high-quality, FDA-compliant components that improve patient outcomes. As we continue to expand our new product introduction (NPI) capabilities, we are seeking a highly skilled Project (Tooling) Engineer to lead tooling development and injection molded product initiatives.
The Project Engineer – NPI Tooling & Molded Products plays a critical role in the development and validation of plastic injection molds for medical device applications. This position requires a deep understanding of tooling design, plastic processing, and FDA validation protocols, along with strong project management and communication skills.
Key Responsibilities:
•Lead the development, validation, and launch of injection molds for new medical device products.
•Manage tooling projects from concept through production, including vendor selection, quoting, and estimating cycle times.
•Draft and execute Engineering Change Orders (ECOs) in accordance with regulatory and quality standards.
•Author technical documentation and reports to support FDA validation protocols and internal quality systems.
•Interface and coordinate with external tooling vendors to ensure timely delivery and adherence to specifications.
•Utilize CAD software (Pro-E or SolidWorks) to review and influence mold designs and component layouts.
•Collaborate cross-functionally with Quality, Manufacturing, and R&D teams to ensure successful project outcomes.
•Identify and implement creative engineering solutions to complex tooling and molding challenges.
•Ensure positive and professional interactions with internal teams and external partners, promoting a culture of respect, problem-solving, and continuous improvement.
Please apply to the position if you meet the criteria below:
•A minimum of 7 years experience working in a highly regulated manufacturing environment (medical device is preferred)
•Experience designing, developing and building plastic injection molds
•A strong understanding of plastic processing and mold development
•Experience quoting or estimating projects
•Comfortable using CAD, Pro-E or SolidWorks
•Team player who enjoys collaborating with others
Benefits Include
•Low cost medical/dental/vision
•Yearly Performance Reviews with Merit increases
•15 days PTO + 10 days sick leave + Company Holidays
Job Types: Full-time, Permanent
Pay: $100,000.00 - $120,000.00 per year
Benefits:
•Flexible spending account
Schedule:
Work Location: In person