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Genentech

Biotech firm creating medicines via R&D

Device Technology Deployment Manager - Assembly & Packaging

Manufacturing EngineeringConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A Bachelor's or Master's degree in Engineering, such as Mechanical Engineering, Automation, Biomedical Engineering, Process Engineering, or a related technical discipline.
  • At least 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 taking complex manufacturing equipment from concept and User Requirements Specification (URS) through design, Factory Acceptance Testing (FAT), Site Acceptance Testing (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.
  • 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 current Good Manufacturing Practice (cGMP) and relevant medical device quality requirements, including ISO 13485 and applicable FDA requirements.
  • Fluency in English.
  • Willingness to travel internationally up to approximately 25%, particularly for supplier activities, FATs, and site implementation.

Responsibilities

  • 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.

Desired Qualifications

  • Experience with final device assembly technologies and automated packaging equipment is strongly preferred.

About the Company

Genentech

Biotech firm creating medicines via R&D

Genentech develops medicines and therapies to address unmet medical needs through extensive biotechnology research and development. Its products include biologic and small-molecule treatments prescribed by healthcare providers and sold through partnerships with suppliers and health systems. It differentiates itself with a large R&D footprint, a vast patent portfolio, and FDA Breakthrough Therapy Designations that accelerate promising therapies. Its goal is to advance medical science and deliver high-quality, effective therapies that improve patient health while supporting the broader medical community.

Company size
10,001+
Company stage
IPO
Headquarters
San Francisco, CA
Founded
1976

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