We have a unique opportunity for a Programme Director to join our expanding team. We are looking for an individual with experience in developing medical products ideally with some start up experience.Operating within the Philips HealthTech Incubator divison, we are an independent business involved in the Design, Development, Production, Marketing and Distribution of innovative In Vitro Diagnostic products and Tele-health solutions that are created to make a difference for personal healthcare. This position reports into the General Manager.For the right candidate there is also the opportunity to be based out of the Netherlands.
Your responsibilities
Working Closely With The Operations Director You Will Have Control Of
· Management of all activities pertaining to Design and Development of novel in vitro diagnostic applications within Philips Home Clinical Monitoring Team and with sub -contractors.
· Ensuring Design and Development timelines are prepared, managed and product is delivered to schedule.
· Liaison with Management Team to ensure Sales/Marketing requirements and regulatory Design Inputs are fully met.
· Ensuring Design Development is effectively managed, resourced through to design transfer into production.
We are at an important stage in our development and there will be a need to help set up systems and processes to ensure success with the business in helping patients across the globe.
· Management and coordination of the various sub-contracted Design& Development activities across several companies, and management of Philips resource within those companies where appropriate
· Tracking and maintaining weekly updates for development schedules via Use of Gantt charts
· Leadership and Programme Management of the development operations for all activities from raw materials to final assembled product
· Develop/provide ongoing education within Design Development at site level to ensure knowledge is captured, retained and dissipated throughout the group.
· Preparation of budgets and expenditure forecasts for internal and external Development sites.
· Ensuring all Validation activities required for the entire Development and transfer process are effectively completed.
· Ensuring Philips Privacy rules are maintained within an expanding business operation (multi-territory, multiple disease/HCP’s)
· Management of interactions between Home Training organisation/s and CRM/SAP system
· Operation activities in compliance with ISO13485, FDA 21CFR 820 and other relevant regulatory requirements to ensure global compliance. QC for all components of HCM products
We are looking for
A candidate with solid experience in programme managing the development of medical products as well as management of dispersed multidiscipline teams. Good management skills with ability to influence internal and external parties.
· Technical expertise and detailed knowledge for Design and Development activities
· Managerial ability to deal with operational and personal issues through liaison within Philips
· Management Experience within IVD Development environment at senior level
· Direct experience of working within Quality System operation/Regulatory control
· Inquisitive personality, attention to detail, meticulous approach
· Able to supervise staff on and off site
· Extremely good and proactive communication skills
· Proactive approach/positive attitude
· Comfortable interacting with staff at multi- levels
· Management Experience within IVD Development environment at senior level
· Direct experience of working within Quality System operation/Regulatory control
· Ability to work with ERP system operation (eg. SAP)
· Relevant technical experience with HCM/similar IVD or MDD products
Pass it on for Referral Bonus. Not the right role for you, but know someone we should meet? Share with him to earn $1,000 referral bonus.
Subscribe to us
100% Free.
close