New Product Development Manager

TekniPlex•Madison, WI

1d•$103,000 - $130,000

About The Position

The New Product Development (NPD) Manager leads the technical development, commercialization, and scale-up of advanced medical packaging solutions in a high-precision, fast-paced manufacturing environment. The role oversees complex, multi-substrate projects involving flexible films, foils, medical-grade printing, and functional coating of porous substrates. The position reports to the Director of Innovation. The NPD Manager connects medical device OEMs, Regulatory Affairs, and Operations to ensure new product introductions comply with ISO 13485 and ISO 11607 while supporting manufacturing efficiency. The role manages projects from concept through commercial scale-up, leads Stage-Gate governance, transfers products from pilot or lab scale to commercial production, and supports design controls, validation, technical customer advisory, and commercial feasibility assessments. The position requires collaboration with Quality and Regulatory, Commercial and Product Management, Operations and Production, Procurement, and customers. Salary range: $103,000 to $130,000, based on experience.

Requirements

Bachelor’s degree in Packaging Science, Chemical Engineering, Material Science, Polymer Chemistry, or a closely related technical discipline.
6–10 years of experience in product development or process engineering within medical packaging, medical device, pharmaceutical, or food manufacturing.
Proven experience managing technical projects using structured methodologies and making decisions.
Strong knowledge of raw materials, validation protocols, and process optimization.
Ability to interpret and apply regulatory and customer-specific requirements.
Deep understanding of flexible webs, films and foils, solvent- or water-based printing, barrier properties (WVTR and OTR), sealants, and the physical characteristics of porous substrates.
Practical exposure to precision surface coating (solvent- or water-based), extrusion lamination, and medical-grade flexographic or digital printing.
In-depth working knowledge of ISO 11607, ISO 13485, and FDA Quality System Regulations.
Proficiency in risk assessment tools, specifically d/pFMEA.
Ability to read and interpret technical procedures, blueprints, and technical drawings.
Ability to communicate technical information effectively in writing and in presentations to employees, managers, clients, customers, and the public.
Ability to solve practical problems, interpret varied instructions, define problems, collect data, establish facts, and draw valid conclusions.
Ability to meet the described physical demands, including standing, walking, handling materials, and regularly lifting or moving up to 10 pounds and frequently up to 50 pounds.

Nice To Haves

Printing and/or extrusion experience.
Statistical analysis experience; Minitab and Six Sigma are preferred.

Responsibilities

Lead new product introduction projects from initial customer or plant concept through successful commercial manufacturing scale-up.
Own the site project and Stage-Gate process, ensuring technical, quality, and financial milestones are achieved before phase progression.
Develop and manage project timelines, identify critical-path risks, and execute mitigation plans.
Lead technical transfer from pilot or laboratory scale to high-speed commercial production lines, including extrusion/lamination, precision coating, and printing.
Design, author, and execute industrial trial protocols to establish optimum production settings for line speeds, temperatures, tension, and drying profiles.
Troubleshoot manufacturing defects during trial phases, including web handling issues, coating voids, delamination, and ink adhesion failures.
Act as a subject matter expert in customer and vendor interactions.
Author and maintain the Design History File and associated technical documentation in compliance with ISO 13485.
Facilitate and lead Design and Process Failure Mode and Effects Analyses (DFMEA/PFMEA).
Support Validation and Quality Engineering in developing and executing IQ/OQ/PQ protocols for new equipment, tooling, or material formulations.
Support and own parts of the product portfolio, including creating, updating, and monitoring technical documents.
Serve as the primary technical interface for medical device OEM customers and translate functional packaging requirements into manufacturing specifications.
Advise on material selection, including polymer barrier properties, sealant layers, and adhesive chemistry, for sterilization modalities such as EO, Gamma, and E-beam.
Support Commercial and Product Management in assessing technical feasibility, raw material constraints, and manufacturing cost estimates for new RFQs.
Coordinate and schedule manufacturing trials with Operations and Production while minimizing disruption to commercial volume.
Work with Procurement to secure medical-grade raw materials, manage supplier specifications, and support supply continuity.
Present technical findings to customers and provide educational seminars on best practices.