Global Device Platform Lead - Strategy & Lifecycle

OneWe Reach; Newark, Northern (NJ, KY); Hybrid; USD 143,000 - 238,000; Full time

Benefits offered by this job

Health care and insurance benefits

Retirement benefits

Paid holidays and vacation

Parental and caregiver leave

Job summary

GSK is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology to own the device platform and drive global lifecycle management. The role requires leading cross-functional teams, managing technology transfer, and ensuring regulatory compliance across FDA and MDR standards.

The position emphasizes strategic collaboration with Strategy, Procurement, Quality, and Logistics to optimize device manufacturing and reduce COGs, with periodic international travel expected.

Qualifications

• Bachelor’s degree in engineering or Science Degree (e.g. Process/Mechanical Engineering, Materials Science, Biomedical Engineering/ Chemistry)
• 10+ years' experience in Medical Device Manufacturing environment OR Master’s Degree with 5+ years in Medical Device Manufacturing environment
• Experience in pharmaceutical/medical device GMP, regulatory environment, ISO standards and related legislation (DHF, MDR, FDA QSR)

Responsibilities

• Serve as SPOC technical SME between device suppliers and MSAT site teams for project improvements and risk management.
• Develop and deliver robust supply strategy for the Device platform with cross-functional collaboration.
• Lifecycle manage device platform including technology transfer from R&D and post-approval changes.
• Ensure global device manufacturing processes meet specifications and are efficient.
• Maintain Device design and regulatory documentation (DHF/Technical file) for global standardization.
• Support Device Director and cross-functional teams on Continuous Improvement and global projects.
• Communicate technical device challenges across R&D and supply chain to enable success.
• Drive innovation through new device technologies and digital data management initiatives.
• Lead risk management activities and act as risk owner when required.

Skills

Technical leadership

Device manufacturing

Risk management

GxP regulations

Regulatory knowledge

Technology transfer

Cross-functional collaboration

Data-driven decisions

Process optimization

Project leadership

Education

Bachelor’s in engineering

Master’s in engineering

Tools

Regulatory documentation tools

DHF/Technical file management

Job description

GSK is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology to own the device platform and drive global lifecycle management. The role requires leading cross-functional teams, managing technology transfer, and ensuring regulatory compliance across FDA and MDR standards.

The position emphasizes strategic collaboration with Strategy, Procurement, Quality, and Logistics to optimize device manufacturing and reduce COGs, with periodic international travel expected.