Global Device Automation Deployment Lead

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 110,000 - 204,000; Full time

Job summary

Genentech, a Roche subsidiary, seeks a Device Technology Deployment Manager focused on automated device assembly and packaging. You will lead complex technology deployment projects across our global network, translating product requirements into scalable manufacturing solutions and providing technical leadership throughout design, qualification, and production rollout.

You bring a strong background in device manufacturing, ISO 13485/GDP, and cGMP with 7+ years in regulated environments, and are

Qualifications

• Bachelor's (B.S.) or Master's (M.S.) degree in Engineering or related technical discipline.
• 7+ years of relevant experience in medical device manufacturing or similarly regulated environments.
• Strong hands-on experience with automated device assembly equipment and processes.
• Experience with final device assembly technologies and automated packaging equipment is strongly preferred.
• Experience taking complex manufacturing equipment from concept through design, FAT, SAT, commissioning, qualification, and production implementation.
• Solid understanding of cGMP and ISO 13485/FDA requirements.
• Fluency in English and willingness to travel internationally up to ~25%.

Responsibilities

• Lead end-to-end deployment of automated device assembly and packaging technologies from concept through industrial rollout.
• Translate product and process requirements into robust equipment concepts and scalable manufacturing solutions.
• Provide technical leadership for development and deployment of automated assembly platforms.
• Drive equipment and process tech initiatives to improve robustness, efficiency and future readiness.
• Evaluate new assembly technologies through feasibility studies and pilots for potential deployment.
• Lead equipment design reviews, machine risk assessments, FAT/SAT, commissioning, qualification, and process validation.
• Ensure deliverables meet product and process requirements in collaboration with Site Engineering, Quality, and external suppliers.
• Lead collaboration with equipment suppliers including selection, technical clarifications, and documentation reviews.

Skills

Project leadership

Stakeholder management

Communication

Negotiation

Education

Bachelor's or MS in Engineering

Tools

UR S through validation

Job description

Genentech, a Roche subsidiary, seeks a Device Technology Deployment Manager focused on automated device assembly and packaging. You will lead complex technology deployment projects across our global network, translating product requirements into scalable manufacturing solutions and providing technical leadership throughout design, qualification, and production rollout.

You bring a strong background in device manufacturing, ISO 13485/GDP, and cGMP with 7+ years in regulated environments, and are