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Director Engineering Medical Device Jobs in Wisconsin

Crown Medical, Inc.

WI · On-site

$60 - $80/hr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... information as directed by management to grow market share. * Consistently develop a ...

Collabera

Engineering project manager

Madison, WI · On-site

... direct placement services to global 2000 corporations. For consultants and employees, Collabera ... Industry: Healthcare/Medical device Title: Engineering project manager Location: Madison, WI 53718 ...

Gehc

Director of Engineering, Architecture

Waukesha, WI

$164K - $246K/yr

Summary GE HealthCare is seeking a Director of Engineering, Architecture to lead the architecture ... This platform enables AI-powered medical imaging, real-time visualization, and enterprise-scale ...

Verily Life Sciences LLC

WI · On-site

$125 - $150/hr

Demonstrated experience applying IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 62366 (Usability Engineering), and AAMI TIR57 within a regulated software ...

DeKalb Health

Engineering Manager

Neenah, WI · On-site

$125 - $150/hr

Performs other tasks, as required or directed. CORE VALUES & GUIDING PRINCIPLES * Understands ... Experience in medical device quality processes under FDA 21 CFR 820 and ISO 13485. * Strong ...

Smiths Machine

Regulatory Quality Engineer

Kenosha, WI · On-site

$70K - $90K/yr

Acts as a direct contact for FDA. Ensures FDA registrations and device listings are current ... medical device manufacturing industry and in the quality engineering role, and/or training, * or ...

Resonetics

Quality Engineering Technician

Hudson, WI · On-site

$21 - $30/hr

Overview Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion ...

Resonetics

Quality Engineering Technician

Hudson, WI · On-site

$21 - $30/hr

Overview Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion ...

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Director Engineering Medical Device information

What is a director engineering medical device?

A Director of Engineering in the medical device industry leads the design, development, and testing of medical technologies while ensuring compliance with regulatory standards. They manage engineering teams, oversee project timelines, and collaborate with cross-functional departments, including R&D, quality assurance, and manufacturing. Their role involves strategic planning, resource allocation, and risk management to drive innovation and bring safe, effective medical devices to market.

What are the key skills and qualifications needed to thrive in the director engineering medical device position?

To excel as a Director Engineering Medical Device, you need extensive experience in engineering management, regulatory compliance (such as FDA and ISO standards), and a background in medical device design or related technical fields. Proficiency with product lifecycle management (PLM) tools, design control systems, and quality management certifications like Six Sigma or PMP are highly valuable. Outstanding leadership, strategic thinking, and the ability to communicate effectively across multidisciplinary teams help set top performers apart. These capabilities are crucial to successfully guide high-stakes projects, ensure regulatory compliance, and drive innovation in a highly regulated industry.

What are the typical challenges faced by a director of engineering in the medical device industry?

A Director of Engineering in the medical device field often navigates complex regulatory requirements while balancing innovation and speed-to-market. They frequently manage cross-functional teams, oversee rigorous testing and verification processes, and must ensure that all products meet strict quality and safety standards. Collaboration with regulatory, clinical, and marketing teams is essential to align technical development with business objectives. Additionally, adapting to evolving technology and changes in regulatory landscapes can present ongoing challenges, making strong leadership and adaptability key assets.

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For Director Engineering Medical Device jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Director Engineering Medical Device jobs in Wisconsin look for?

The top searched job categories for Director Engineering Medical Device jobs in Wisconsin are:

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Cities in Wisconsin with the most Director Engineering Medical Device job openings:

Director Engineering Medical Device jobs near you
Infographic showing various Director Engineering Medical Device job openings in Wisconsin as of July 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

New Product Development Engineer

SPECTRUM PLASTICS MASTER

Pleasant Prairie, WI • On-site

Full-time

Re-posted 22 days ago

Key responsibilities

  • Lead end-to-end development of medical films and flexible packaging solutions, including design, prototyping, process development, validation, and tech transfer.

  • Develop and optimize polymer film extrusion and packaging conversion processes, troubleshoot issues, and collaborate on process scale-up and technology transfer.

  • Manage cross-functional projects through structured development stages, ensuring regulatory compliance, risk mitigation, and timely delivery.

Job description

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.
Key Responsibilities
  • 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, 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.
  • Continuous Improvement: 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.

Qualifications
  • Education & Experience: 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.
  • Medical Packaging & Regulatory Knowledge: 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.
  • Technical & Process Expertise: 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.
  • Project Leadership & Collaboration: 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.
  • Innovation & Problem-Solving: 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.
  • Drive & Adaptability: 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.
  • Travel Requirements: Willingness to travel up to 20% to support customer collaborations, off-site trials, or manufacturing activities as needed.

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