Device Technology Deployment Manager - Assembly & Packaging

About the role

Roche's Global MSAT (Medical Science & Automation Technology) is looking for a Device Technology Deployment Manager focused on automated device assembly and packaging. The role leads complex technology deployment projects from early concept through industrial implementation, working at the intersection of device technology, process engineering, equipment engineering, automation, quality and manufacturing. The position is based in Holly Springs, North Carolina.

Key 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 equipment concepts, technical specifications and scalable manufacturing solutions.
• Provide technical leadership for automated and high-speed assembly and packaging platforms, and evaluate new technologies through feasibility studies, pilots and technical assessments.
• Drive equipment and process technology initiatives to improve manufacturing robustness, efficiency, automation and future readiness.
• Lead equipment design reviews, machine risk assessments, FAT/SAT, commissioning, qualification and process validation, working with Site Engineering, Quality, Device Development, MSAT, Automation and Manufacturing.
• Support equipment suppliers through 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.

Required profile

• Bachelor's or Master's degree in Engineering (Mechanical, Automation, Biomedical, Process Engineering or related).
• 7+ years of experience in medical device, drug-device combination product, pharmaceutical or similarly regulated manufacturing environments.
• Hands-on experience with automated device assembly equipment and processes, preferably drug-delivery devices such as autoinjectors or pen injectors, and associated inspection and handling technologies.
• Demonstrated experience moving equipment from concept and URS through design, FAT, SAT, commissioning, qualification and production implementation.
• Experience supporting process development and technology scaling from feasibility studies through NPI and commercial manufacturing.
• Fluency in English and willingness to travel internationally up to about 25% for supplier activities, FATs and site implementation; relocation benefits are not available.

Required skills

• URS, design reviews, machine risk assessments, commissioning and qualification strategies, process characterization and validation.
• Strong understanding of cGMP, ISO 13485 and applicable FDA requirements.
• Experience working with equipment suppliers and leading technical discussions across multidisciplinary teams.

What we offer

• Expected salary range of $109,900 to $204,100 depending on experience, qualifications and location; actual pay determined by the employer.
• A discretionary annual bonus may be available based on individual and company performance.
• The position qualifies for the benefits described in the original listing.