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Device Technology Deployment Manager – Assembly & Packaging

Roche

Holly Springs, NC; Hillsboro, OROnsitePosted 26 days ago$109,900 - $204,100/year
Full TimeSenior LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

Within Global MSAT, Device Manufacturing Engineering defines and drives manufacturing process characterization, technology development, and industrialization for Roche medical devices and drug-device combination products throughout their lifecycle.

Job description

We are looking for a Device Technology Deployment Manager with a strong focus on automated device assembly and packaging technologies. In this role, you will lead the technical deployment of manufacturing equipment and processes across our global network—translating product and process requirements into robust, scalable, and compliant manufacturing solutions.

The Opportunity

As Device Technology Deployment Manager, you will lead complex technology deployment projects from early concept through industrial implementation. You will work at the intersection of device technology, process engineering, equipment engineering, automation, quality, and manufacturing.

Your key responsibilities include:

  • Lead end-to-end deployment of automated device assembly and packaging technologies, from concept assessment and equipment selection through design, FAT/SAT, commissioning, qualification, and manufacturing implementation.
  • Translate product and process requirements into robust equipment concepts, technical specifications, and scalable manufacturing solutions for device assembly and packaging.
  • Provide technical leadership for the development and deployment of automated and high-speed device assembly and packaging platforms.
  • Drive strategic equipment and process technology initiatives to improve manufacturing robustness, efficiency, automation, and future readiness across the product lifecycle.
  • Evaluate new assembly and packaging technologies through feasibility studies, pilots, and technical assessments and determine their readiness for industrial-scale deployment.
  • Provide technical leadership during equipment design reviews, machine risk assessments, FAT/SAT, commissioning, qualification, and process validation.
  • Ensure critical design, qualification, and validation deliverables are technically sound and aligned with product and process requirements, working closely with Site Engineering, Quality, Device Development, MSAT, Automation, and Manufacturing.
  • Lead technical collaboration with equipment suppliers, including supplier selection, technical clarification, design development, performance management, and review of critical technical documentation.
  • Support the development and harmonization of global manufacturing technology standards and platform solutions for device assembly and packaging.

Who You Are

We are looking for an experienced and technically strong individual who combines deep device manufacturing knowledge with the ability to lead complex technology deployment projects in a global, highly regulated environment.

You bring:

  • A Bachelor's (B.S.) or Master's (M.S.) degree in Engineering, such as Mechanical Engineering, Automation, Biomedical Engineering, Process Engineering, or a related technical discipline.
  • 7+ years of relevant experience in medical device, drug-device combination product, pharmaceutical, or similarly regulated manufacturing environments.
  • Strong hands-on experience with automated device assembly equipment and processes, preferably including drug-delivery devices such as autoinjectors or pen injectors, and associated inspection and handling technologies.
  • Experience with final device assembly technologies and automated packaging equipment is strongly preferred.
  • Demonstrated experience taking complex manufacturing equipment from concept and URS through design, FAT, SAT, commissioning, qualification, and production implementation.
  • Strong understanding of equipment and process development, including URS, design reviews, machine risk assessments, commissioning and qualification strategies, process characterization, and validation.
  • Proven ability to support process development and technology scaling from early feasibility studies through New Product Introduction and commercial manufacturing.
  • Experience working with equipment suppliers and leading technical discussions across multidisciplinary and cross-functional project teams.
  • Solid understanding of cGMP and relevant medical device quality requirements, including ISO 13485 and applicable FDA requirements.
  • Strong communication, negotiation, influencing, and stakeholder management skills across technical functions, manufacturing sites, and external suppliers.
  • Fluency in English and willingness to travel internationally up to approximately 25%, particularly for supplier activities, FATs, and site implementation.

Requirements

  • Bachelor's (B.S.) or Master's (M.S.) degree in Engineering, such as Mechanical Engineering, Automation, Biomedical Engineering, Process Engineering, or a related technical discipline.
  • 7+ years of relevant experience in medical device, drug-device combination product, pharmaceutical, or similarly regulated manufacturing environments.
  • Strong hands-on experience with automated device assembly equipment and processes, preferably including drug-delivery devices such as autoinjectors or pen injectors, and associated inspection and handling technologies.
  • Experience with final device assembly technologies and automated packaging equipment is strongly preferred.
  • Demonstrated experience taking complex manufacturing equipment from concept and URS through design, FAT, SAT, commissioning, qualification, and production implementation.
  • Strong understanding of equipment and process development, including URS, design reviews, machine risk assessments, commissioning and qualification strategies, process characterization, and validation.
  • Proven ability to support process development and technology scaling from early feasibility studies through New Product Introduction and commercial manufacturing.
  • Experience working with equipment suppliers and leading technical discussions across multidisciplinary and cross-functional project teams.
  • Solid understanding of cGMP and relevant medical device quality requirements, including ISO 13485 and applicable FDA requirements.
  • Strong communication, negotiation, influencing, and stakeholder management skills across technical functions, manufacturing sites, and external suppliers.
  • Fluency in English and willingness to travel internationally up to approximately 25%, particularly for supplier activities, FATs, and site implementation.

Benefits

  • Annual bonus
  • Medical, Dental & Vision
  • 401(k) Matching
  • Paid Time Off

Company overview

Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.

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