Senior Manager, Process Development - Medical Devices

Posted 31 July 2023
Salary Negotiable
LocationUnited States of America
Job type Full Time
DisciplineMedical Devices
Contact NameSophie Packer

Job description

Mantell Associates are thrilled to have partnered with one of the most technologically advanced, game changing Medical Device companies who have completely transformed the world of imaging. Due to significant growth in every division they are looking for a Senior Manager for Process Development to join them and act as the bridge between Manufacturing and R&D.

Senior Manager, Process Development - Responsibilities:

  • Leadership and day-to-day Management of a small team (up to 5 people)

  • Manage process validation activities (e.g., development and execution of IQ/OQ/PQ)

  • Manage product scale-up and Design Transfer from R&D to Manufacturing, ensuring that design intent is maintained.

  • Develop work instructions, workmanship standards, process documents, and ensure they are followed by operators.

  • Actively manage Continuous Improvement activities for commercial products,

Senior Manager, Process Development - Requirements:

  • Bsc / Msc / PhD in Mechanical, Biomedical, or Plastics Engineering is highly desirable

  • Prior experience in team / people management is essential

  • Must have worked in the Medical Devices industry preferably focusing on manufacturing

  • Must be experienced in working to ISO 13485

  • Comfortable working cross-functionally and an excellent communicator

  • Any experience with plastics and the relevant manufacturing of will be highly advantageous


Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.