Job description

Imagine: A Career with Purpose and Possibility Picture this: You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact using science, technology, and creativity to tackle real-world challenges. You are part of a company whose work helps improve patient outcomes in healthcare and protects essential consumer goods that people around the world rely on every day. At TekniPlex, you’ll join more than 8,000 colleagues across 12 countries, all united by one purpose: creating safer, smarter solutions that touch daily life. Through our two divisions, TekniPlex Healthcare and TekniPlex Consumer Products, you’ll help shape industries that matter: healthcare, pharmaceutical, food & beverage, beauty, and personal care. Here, your ideas count and your work matters. You’ll be encouraged to think boldly, collaborate across cultures, and keep growing every step of the way. You will help protect the integrity of essential products, support patient safety and comfort, and contribute to innovations that make everyday life better, all while building a career that makes an impact. Because at TekniPlex, you don’t just deliver products – you help shape what’s next. JOB SUMMARY The New Product Development (NPD) Manager leads the technical development, commercialization, and scale-up of advanced medical packaging solutions. Operating within a high-precision, fast paced manufacturing environment, this role oversees complex, multi-substrate projects involving flexible films, foils, medical-grade printing, and functional coating of porous substrates. This position will report to the Director of Innovation. The NPD Manager acts as the critical bridge between medical device OEMs, Regulatory Affairs, and Operations to ensure all new product introductions (NPI) comply with ISO 13485 and ISO 11607 standards while optimizing manufacturing efficiency. The salary range for the role is $103,000 to $130,000. Pay is based on experience. What You’ll Do: Project Management & Stage-Gate Governance • Lead NPI projects from initial customer/plant concept through successful commercial manufacturing scale-up. • Ownership of the site project/ Stage-Gate process, ensuring rigorous technical, quality, and financial milestones are achieved before phase progression. • Formulate and manage comprehensive project timelines, identifying critical path risks and executing proactive mitigation plans. Process Engineering & Manufacturing Scale-Up • Spearhead the technical transfer of new products from pilot/lab scale to high-speed commercial production lines (extrusion/lamination, precision coating, and printing). • Design, author, and execute industrial trial protocols to establish optimum window 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. • Be the SME for Customer and Vendor interactions. Design Controls & Regulatory Compliance • Author and maintain the Design History File (DHF) and associated technical documentation in strict compliance with ISO 13485. • Facilitate and lead Design and Process Failure Mode and Effects Analyses (DFMEA / PFMEA) to systematically eliminate product performance and process safety risks. • Support Validation and Quality Engineering to develop and execute protocols for IQ/OQ/PQ of new equipment, tooling, or material formulations. • In a team environment, support and own part of the product portfolio such as creating/updating and monitoring of all technical documents. Technical Customer Advisory & Commercial Support • Serve as the primary technical interface for medical device OEM customers, translating complex functional packaging requirements into robust manufacturing specifications. • Provide expert guidance on material selection (e.g., polymer barrier properties, sealant layers, adhesive chemistry) tailored to specific sterilization modalities (EO, Gamma, E-beam). • Assist the commercial and the product manager teams in assessing technical feasibility, raw material constraints, and manufacturing cost estimates for new RFQs. Key Cross-Functional Collaborators • Quality & Regulatory: To align on validation strategies, material compliance, and change control procedures. • Commercial & product management: in assessing technical feasibility (presenting), raw material constraints, and manufacturing cost estimates. • Operations & Production: To coordinate and schedule manufacturing trials with minimal disruption to commercial volume. • Procurement: To secure medical-grade raw materials, manage supplier specifications, and ensure long-term supply chain continuity. • Customers: to present you technical findings and or give educational seminars on best in class. QUALIFICATIONS • Bachelor’s degree in Packaging Science, Chemical Engineering, Material Science, Polymer Chemistry, or a closely related technical discipline. • Minimum of 6-10 years of experience in product development or process engineering within a medical packaging, medical device, Pharma or food manufacturing environment. • Printing and/or extrusion experience is a plus. • Proven experience managing technical projects using structured methodologies and having the ability to make decisions. • Strong knowledge of raw materials, validation protocols, and process optimization. • Ability to interpret and apply regulatory and customer-specific requirements. Technical Competencies Material Expertise: • Deep understanding of flexible webs, film/foils, printing (solvent/water based), barrier properties (WVTR, OTR), sealants, and the physical characteristics of Porus substrates Process Knowledge: • Practical exposure to precision surface coating (solvent or water-based), extrusion lamination, and medical-grade printing (flexographic or digital). Standards & Compliance: • In-depth working knowledge of ISO 11607 (Packaging for terminally sterilized medical devices), ISO 13485, and FDA Quality System Regulations. Risk Management: • Proficient in risk assessment tools, specifically d/pFMEA and statistical analysis (Minitab/Six Sigma preferred). TekniPlex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs. Our programs offer you and your family health care coverage and financial security. You can take advantage of life insurance, disability coverage and voluntary benefits for extra financial protection and peace of mind. Plus, our work-life benefits provide support and assistance whenever you need it. Some of your benefits are paid in full by TekniPlex and some costs are shared between you and TekniPlex. Other benefits are made available to you at reasonable group rates. • Medical Coverage • Prescription Drug Coverage • Telemedicine • Dental Coverage • Vision Coverage • Employee Assistance Program • Health Savings Account (HSA) • Flexible Spending Account (FSA) • Basic Term Life/AD&D Insurance • Voluntary Life/AD&D Insurance • Short Term Disability (STD) • Long Term Disability (LTD • Voluntary Buy-Up LTD • Hospital Indemnity • Accident Insurance • Critical Illness • 401(k) Retirement Savings Plan • Daily Pay • Business Travel Insurance • Legal Plan • Identity Protection LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and legibly complete time cards and work orders. Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical. Ability to effectively present information in one-on-one and small groups situations to other employees of the organization. Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public. MATHEMATICAL SKILLS Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent. Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat. The noise level in the work environment is usually moderate The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Equal Opportunity Company Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran’s status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law.

Requirements

Must-haves

Imagine: A Career with Purpose and Possibility
Because at TekniPlex, you don’t just deliver products – you help shape what’s next.
Project Management & Stage-Gate Governance
Lead NPI projects from initial customer/plant concept through successful commercial manufacturing scale-up.
Ownership of the site project/ Stage-Gate process, ensuring rigorous technical, quality, and financial milestones are achieved before phase progression.
Formulate and manage comprehensive project timelines, identifying critical path risks and executing proactive mitigation plans.
Process Engineering & Manufacturing Scale-Up
Spearhead the technical transfer of new products from pilot/lab scale to high-speed commercial production lines (extrusion/lamination, precision coating, and printing).
Design, author, and execute industrial trial protocols to establish optimum window 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.
Be the SME for Customer and Vendor interactions.
Design Controls & Regulatory Compliance
Author and maintain the Design History File (DHF) and associated technical documentation in strict compliance with ISO 13485.
Facilitate and lead Design and Process Failure Mode and Effects Analyses (DFMEA / PFMEA) to systematically eliminate product performance and process safety risks.
Support Validation and Quality Engineering to develop and execute protocols for IQ/OQ/PQ of new equipment, tooling, or material formulations.
In a team environment, support and own part of the product portfolio such as creating/updating and monitoring of all technical documents.
Technical Customer Advisory & Commercial Support
Serve as the primary technical interface for medical device OEM customers, translating complex functional packaging requirements into robust manufacturing specifications.
Provide expert guidance on material selection (e.g., polymer barrier properties, sealant layers, adhesive chemistry) tailored to specific sterilization modalities (EO, Gamma, E-beam).
Assist the commercial and the product manager teams in assessing technical feasibility, raw material constraints, and manufacturing cost estimates for new RFQs.
Key Cross-Functional Collaborators
Quality & Regulatory: To align on validation strategies, material compliance, and change control procedures.

Nice-to-haves

Printing and/or extrusion experience is a plus.
Proficient in risk assessment tools, specifically d/pFMEA and statistical analysis (Minitab/Six Sigma preferred).

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: ukg
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401(K)