Product Development Engineer

New Product Development Engineer

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.

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.

• Flexibles Packaging New Product Design & Development:
  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.
• Flexibles Packaging & Conversion Process Development:
  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.
• Project Management & Risk Mitigation:
  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.
• Regulatory Compliance & Process Validation:
  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.
• Customer Collaboration & Technical Leadership:
  Act as a customer-facing technical leader for healthcare packaging projects. Partner closely with medical device clients and internal teams (marketing, product management, quality,…