Medical Packaging NPD Lead: From Lab to Scale-Up

TekniPlex; Madison (WI); Presencial; USD 103.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Coverage

Prescription Drug Coverage

Vision Coverage

401(k) Retirement Savings Plan

Daily Pay

Health Savings Account (HSA)

Descripción de la vacante

TekniPlex Wisconsin is seeking a New Product Development Manager to lead medical packaging projects from concept to scaled production, ensuring ISO 13485 and ISO 11607 compliance while optimizing manufacturing efficiency.

You will bridge medical device OEMs, Regulatory Affairs, and Operations, guiding multi-substrate developments in films, lamination, printing, and coating. Salary range $103,000–$130,000.

Formación

• Bachelor’s degree in a technical field (Packaging Science, Chemical Engineering, or similar).
• 6–10 years in product development or process engineering in medical packaging/device/pharma or food manufacturing.
• Experience with extrusion/printing is a plus.
• Proven ability to manage technical projects with structured methodologies and make decisions.
• Strong knowledge of raw materials, validation protocols, and process optimization.
• Ability to interpret regulatory and customer requirements.

Responsabilidades

• Lead NPI projects from concept through successful commercial scale-up.
• Own site Stage-Gate process with milestones for technical, quality, and financial targets.
• Coordinate timelines, identify risks, and implement mitigation plans.
• Transfer technology from pilot to high-speed production (extrusion/lamination, coating, printing).
• Develop validation protocols for IQ/OQ/PQ of equipment, tooling, or materials.
• Serve as SME in customer and vendor interactions.

Conocimientos

Project management

Regulatory compliance

Technical problem-solving

Cross-functional collaboration

Vendor coordination

Decision making

Educación

Bachelor’s degree in Packaging Science, Chemical Engineering, Material Science, Polymer Chemistry, or related discipline

Herramientas

DFMEA/PFMEA

Minitab

ISO 13485 familiarity

Descripción del empleo

TekniPlex Wisconsin is seeking a New Product Development Manager to lead medical packaging projects from concept to scaled production, ensuring ISO 13485 and ISO 11607 compliance while optimizing manufacturing efficiency.

You will bridge medical device OEMs, Regulatory Affairs, and Operations, guiding multi-substrate developments in films, lamination, printing, and coating. Salary range $103,000–$130,000.