Associate Director, New Product Introduction (Device Manufacturing)
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Associate Director, New Product Introduction role is responsible for leading new product introduction and technical transfer activity with the device manufacturing CMOs engaged by our client.
- In collaboration with the CMO, coordinates the implementation of new manufacturing processes, selection of manufacturing equipment, assembly line installation and optimisation
- Ensures that DFM requirements are considered and met during product development and technical transfer
- Coordinates the resolution of device assembly and product manufacture issues to ensure continued device manufacturing operations readiness.
- Coordinates process optimisation to deliver production line efficiency targets. Provides technical guidance and oversight to the selection and implementation of assembly automation and associated tooling
- Supports process and equipment validation including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)Works in close alignment to Sense supply chain team to structure device BOMs that enable robust and efficient manufacture and packaging of all Sense device products Leads and coordinates continuous improvement initiatives with device manufacturing CMOs
- Ensures that all processes and techniques employed are aligned to LEAN/CI manufacturing principles
- Collaborates closely with internal and external Engineering, Manufacturing and Quality teams to drive high device product yield from initial product launch
- Actively participates in all design reviews and pFMEAs to ensure seamless technical transfer of new product programs to CMOs
- ~10 years’ experience of working in Medical Device Industrialisation and/or New Product Introduction
- ~10 years’ experience of working with multi-site, multi-region Medical Device manufacturing programs
- ~10 years’ experience of working with global, integrated CMOs on commercial Medical Device programs
- ~5 years’ experience of working remotely
- Excellent communication skills – equally comfortable in dialogue with senior management and/or process operators
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
your application has been submitted