Molding Process Validation Engineer Lake Geneva, WI

Molding Process Validation Engineer

Plas-Tech Engineering – Lake Geneva, WI.

The Validation Engineer is responsible for all aspects of validation engineering, with a primary focus on scientific injection molding using electric presses. This role covers IQ/OQ/PQ activities, validation deliverables, and project management to ensure compliance with FDA, ISO 13485, and customer requirements. The engineer will develop and maintain molding guidelines, optimize processes for efficiency, quality, and productivity, ensure production feasibility, implement manufacturing strategies, investigate root causes, establish procedures, support new product launches, verify processes, troubleshoot, and assist production areas as needed.

• Develop, execute, and document IQ/OQ/PQ protocols for equipment, processes, and software.
• Ensure validation practices meet FDA/medical regulatory requirements and customer specifications.
• Maintain validation master plans, periodic reviews, and ensure all documentation is current.
• Write technical reports and prepare and make effective presentations.
• Proven experience as an Injection Molding Process Engineer within the injection molding industry, preferably with medical device manufacturing experience. Master Molder certification is a plus.
• Strong problem‑solving skills and ability to apply engineering principles to identify and resolve process‑related issues.
• Apply scientific molding principles (decoupled molding, cavity pressure monitoring, DOE) to optimize process capability on electric presses.
• Analyze molding and production data to identify trends and implement corrective actions.
• Support installation, qualification, and validation of new electric molding machines and tooling.
• Coordinate validation project scope, timelines, and deliverables across departments.
• Develop and manage validation master lists, KPIs, and report on project status internally and externally.
• Perform risk analysis (FMEA) and ensure inputs/outputs meet regulatory requirements.
• Generate and maintain SOPs, work instructions, and validation protocols.
• Support qualification and requalification of sterilization processes.
• Collaborate with Manufacturing, Quality, Regulatory, and R&D to support product launches, process improvements, design reviews, and troubleshooting.
• Provide technical guidance during root cause analysis and CAPA activities.
• Drive process improvements to enhance product quality, process efficiency, and operator safety.
• Assist in validating manufacturing procedures, tooling, and fixtures.
• May supervise indirect reports or contract associates as needed.
• Provide training and guidance on validation activities and best practices.

• Associate’s degree in a relevant field required;
  Bachelor’s degree preferred.
• Accredited certifications (CQA, CQE, CQM, Clean Room, NC/CAPA) are a plus.
• Minimum 3 years in manufacturing with project coordination and IQ/OQ/PQ responsibilities, preferably in a medical device (FDA 21 CFR 820 or ISO 13485) or pharmaceutical environment.
• Strong knowledge of validation methods, statistical process control, and regulatory requirements.
• Proficiency in statistical tools (Minitab, JMP) and DOE methodology.
• Excellent documentation, organizational, and communication skills.
• Advanced computer skills (Microsoft Office; Microsoft Project a plus).

• Experience with automation/robotics integration in molding processes.
• Understanding of ISO 11135, ISO 11137, and ISO 14971 as they apply to medical device products and processes.

Light to medium physical activity; ability to stand, walk, sit, and use hands.

• Occasional lifting up to 20 pounds.
• Work in well‑lit, climate‑controlled office, production, and warehouse areas.
• Color vision required.

Standard hours: 7:00 am – 5:00 pm, on‑site; infrequent off‑shift work may be required.

Pay: $85,000.00 – $ per year.

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location:

In person.