VALIDATION ENGINEER in Lake Geneva, Wisconsin at Plas-Tech Engineering LLC

Join Plas-Tech Engineering: Wisconsin's Manufacturer of the Year

Be part of a team that makes a real difference. At Plas-Tech Engineering, you'll help bring new medical technologies to market and improve people's lives, all while working alongside a diverse, dedicated team at a leading medical manufacturer.

Why You'll Love Working Here

• Award-winning employer: Recognized as Wisconsin's Manufacturer of the Year
• Growth opportunities: We're expanding fast and adding motivated, enthusiastic people to our team
• Customer focus: Our customers and employees are our #1 priority
• Meaningful work: Your work supports the development of life-changing medical products

Position Summary

We are seeking an experienced, detail-oriented Injection Molding Process Validation Engineer to lead process, mold, and equipment validation (IQ/OQ/PQ). You will support the transition from development to commercial manufacturing, ensuring robust, repeatable processes that meet applicable ISO 13485, IATF 16949, and cGMP requirements.

Ready to make a difference? Apply today and become part of a company that is growing, customer-driven, and invested in its people.

• Scientific Molding & Process Optimization: Apply scientific molding principles (e.g., RJG methodologies) to establish robust processing windows, DOE (Design of Experiments), and cycle time optimizations.
• Validation Management: Execute protocols, and reports for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of injection molding machines, auxiliary equipment, and molds.
• Cross-Functional Collaboration: Work closely with Quality Assurance, Tooling, Manufacturing Operations, and R&D teams to transfer new products from development to full-scale manufacturing.
• Project Management & Reporting: Coordinate validation project scope, timelines, and deliverables across departments.
• Engineering Support: Work with engineering using processing experience to assist in design of world class molds.
• Supervisory & Training : May supervise indirect reports or associates as needed. Provide training and guidance on validation activities and best practices.

Required Qualifications

• Education: Bachelor’s degree in Plastics Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
• Experience: Minimum of 3–5 years of hands-on experience in injection molding process engineering and validation within a regulated manufacturing environment (Medical Device, Automotive, or Aerospace preferred).
• Validation Expertise: Proven track record in writing and executing IQ/OQ/PQ protocols and reports for injection molding equipment and tooling.
• Technical Knowledge: Strong understanding of thermoplastic materials, mold design, cavity pressure monitoring, and auxiliary equipment.

Preferred Skills & Experience

• Certifications: RJG Master Molder (Level I or II) certification or equivalent scientific molding training.
• Software: Knowledge of Nautilus Software
• Statistical Tools: Proficiency in statistical software (e.g., Minitab) for capability studies (CpK, PpK) and DOE.
• Project Management: Demonstrated ability to manage multiple validation projects simultaneously, meeting strict project timelines.
• Soft Skills: Excellent written and verbal communication skills, with strong technical writing abilities and a collaborative mindset.