New Product Development Engineer

Spectrum Plastics GroupPleasant Prairie, WI
Onsite

About The Position

DuPont™ Spectrum™ Healthcare Solutions is seeking a New Product Development Engineer – Medical Films & Flexibles Packaging to drive advanced packaging design (films & conversion) & process development for critical healthcare and medical device applications. This technical role offers the opportunity to lead high-impact new product and process development programs from concept through commercialization within a world-class R&D and manufacturing environment. (Location – Pleasant Prairie, WI) Role Overview Lead end-to-end development of medical films and flexible packaging solutions, applying deep expertise to design, scale-up novel packaging technologies that meet stringent medical device requirements. Primary job scope includes hands-on new product and process development, and project leadership all the way from translating customer needs into innovative packaging designs and materials, through prototyping, pilot-scale process development, validation (IQ/OQ/PQ), and tech transfer to full-scale commercial launch. By applying scientific rigor and project management best practices, you will help expand and grow DuPont Spectrum Life Sciences medical films & packaging innovation portfolio, while ensuring regulatory compliance and quality reliable performance.

Requirements

  • Bachelor’s degree in Materials Science, Polymer Science, Chemical Engineering, or related field with 10+ years of industry experience (or 5+ years experience with advanced degree (Masters or Ph.D.) in new product development, R&D, or process engineering roles.
  • Demonstrated experience in polymer film extrusion and flexible packaging conversion processes is highly desired, especially for medical or pharmaceutical packaging applications.
  • Strong knowledge of medical device packaging requirements and standards (e.g., ISO 11607, ISO 13485, FDA regulations).
  • Familiarity with sterilization processes (EtO, radiation, etc.) biocompatibility considerations.
  • Experience with risk management and design control in regulated product development (FMEA, verification/validation, traceability) is a plus.
  • Hands-on skills in polymer processing and packaging engineering, including film extrusion, coating/lamination, thermoforming, sealing, and related testing methods.
  • Proficiency in process development and validation (e.g., executing IQ/OQ/PQ), and in applying statistical analysis tools (DOE, Minitab or similar) for process optimization and problem solving.
  • Ability to interpret engineering drawings and specifications for precise, high-quality components.
  • Proven ability to lead complex projects and coordinate cross-functional teams with minimum guidance.
  • Strong project management skills capable of organizing and driving multiple projects to completion, balancing technical depth with timeline and budget constraints.
  • Excellent communication and interpersonal skills, with a track record of effective collaboration across R&D, manufacturing, quality, regulatory, and commercial teams.
  • Creative thinker with a passion for innovation in materials and processes.
  • Demonstrated success in solving challenging technical problems through analytical thinking and experimentation.
  • Evidence of innovation outputs (such as patents, published research, or commercialized products) is valued.
  • Self-motivated and results-oriented, able to thrive in a dynamic environment.
  • Adaptable and resilient, with the ability to manage multiple priorities and adjust to evolving project needs.
  • Committed to continuous learning, high-quality work, and professional growth.
  • Willingness to travel up to 20% to support customer collaborations, off-site trials, or manufacturing activities as needed.

Nice To Haves

  • Experience with risk management and design control in regulated product development (FMEA, verification/validation, traceability) is a plus.

Responsibilities

  • Ideate and develop new medical-grade films and flexible packaging form factors tailored for healthcare applications such as medical devices.
  • Translate customer and application requirements into clear design specifications and structure–property-process hypotheses to optimize performance requirements such as barrier properties, mechanical strength, and compatibility with sterilization methods.
  • Lead prototype development, process development, testing of films (multi-layer), laminates, and form factors (e.g. pouches, header bags, conversion films) that ensure sterile barrier integrity and durability for medical device packaging.
  • Develop and optimize polymer film extrusion (blown film) and packaging conversion processes (e.g. film casting, slitting, pouch forming, sealing).
  • Scale up new products from prototyping concepts through pilot trials to manufacturing, ensuring processes are robust, efficient, and capable of high-quality output.
  • Collaborate with manufacturing engineers on process scale-up and technology transfer to establish process parameters, standard operating, and procedures
  • Troubleshoot complex process issues using root cause analysis, and implement corrective and preventive actions to continuously improve yield, reliability, and product quality.
  • Lead and drive cross-functional new product development project teams through a structured stage-gate development process, from concept to commercial launch.
  • Develop and manage project plans defining scope, timeline, resource needs, and critical milestones.
  • Proactively identify and mitigate risks (technical, regulatory, or timeline) using risk management practices (e.g., DFMEA/PFMEA) and implement contingency plans to keep projects on track.
  • Provide regular updates and data-driven reports on progress and utilize proper escalation to ensure project commitments on schedule, cost, and quality are met.
  • Ensure all new packaging designs and processes meet medical device packaging standards and regulations (e.g., ISO 11607, FDA QSR, ISO 13485).
  • Lead development of design verification and validation plans for packaging (including sterilization, shelf-life/aging, seal integrity, distribution simulation) and oversee execution of IQ/OQ/PQ process validations to demonstrate compliance and robust performance.
  • Maintain meticulous technical documentation (specifications, protocols, reports) aligned with design control and quality system requirements throughout development.
  • Act as a customer-facing technical leader for healthcare packaging projects.
  • Partner closely with medical device clients and internal teams (marketing, product management, quality, operations) to align development with customer needs and ensure successful product integration.
  • Deliver clear and compelling technical presentations, progress updates, and design reviews to customers and stakeholders.
  • Champion a customer-centric approach within R&D, ensuring excellent communication, service, and responsiveness to build confidence in DuPont’s packaging solutions.
  • Foster a culture of continuous improvement in packaging technology.
  • Explore new materials, sustainable solutions, and advanced processing techniques (e.g., recyclable films, high-barrier coatings) to differentiate DuPont’s offerings.
  • Apply statistical methods and data-driven problem-solving (Design of Experiments, DOE; process capability analysis; Minitab or similar tools) to characterize processes and optimize product performance.
  • Document learnings, contribute to intellectual property (patents), and leverage insights to refine best practices and improve time-to-market for new products.
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