Associate Director, Device Lead

Job Summary

Required Qualifications

• •Bachelors in engineering or a Science Degree (e.g. Process/Mechanical Engineering, Materials Science, Biomedical Engineering/ Chemistry)
• •10+ years' experience in Medical Device Manufacturing environment
• •Masters Degree with 5+ years of experience in Medical Device Manufacturing environment
• •Experience working in a pharmaceutical and/or medical device GMP, regulatory environment
• •Relevant ISO standards
• •Specific additional legislation needs for medical devices e.g. DHF, MDR, FDA Medical Device guidance
• •Knowledge of current GMP's, ICH Guidelines and FDA QSR and EU MDR device requirements
• •Familiar with regulatory registration processes by FDA, EMA, and MHRA
• •Specialize in Regulations and ISO standards, medical device requirements and global device and combination product regulations such as 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971
• •Knowledge of Injection Mold Tooling Design & Processing
• •Knowledge of Device Polymers and Materials Engineering
• •Knowledge of Springs / Wire Forming
• •Knowledge of Device Testing and Lab Management
• •Knowledge of Mathematic Modelling
• •Knowledge of Device automated assembly techniques
• •A working understanding of data science including digital data infrastructure, visualization, and statistical analysis
• •Knowledge of current GMP's, ICH Guidelines and FDA QSR and EU MDR device requirements and familiar with regulatory registration processes by FDA, EMA, and MHRA
• •Specialize in Regulations and ISO standards, medical device requirements and global device and combination product regulations such as 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971
• •Knowledge of Injection Mold Tooling Design & Processing
• •Knowledge of Device Polymers and Materials Engineering
• •Knowledge of Springs / Wire Forming
• •Knowledge of Device Testing and Lab Management
• •Knowledge of Mathematic Modelling
• •Knowledge of Device automated assembly techniques

Desired Qualifications

• •Knowledge of pharmaceutical development activities and processes adopted by R&D relating to product development, NPS and Technology Transfer
• •Good understanding to enable management of device assembly, metrology & plastics testing techniques & procedures and GSK Specification & Drawing systems
• •Experience leading device groups in a global matrix environment with track record of successful global asset lifecycle management
• •Operate independently within their sphere of influence and work with multiple stakeholders across global business units internally and externally
• •Strong interpersonal and leadership skills
• •Committed team player prepared to work in and embrace a team-based culture
• •Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines
• •Strong verbal and written communication skills
• •Excellent judgment
• •Able to priorities and decide appropriate courses of actions
• •Effective at implementing decisions
• •Proven track record
• •A working understanding of data science including digital data infrastructure, visualization, and statistical analysis