Hobson Prior are looking for a Technical Lead – Device Development to join a global pharmaceutical company that focuses on improving the quality of peoples lives through delivering pioneering medicines and vaccines. This position will aim to deliver successfully the project in time and on budget and will be based in Germany on a contract basis.
- Manage sub-projects within a major medical combination product development project, combination product, autoinjector.
- Leading a multidisciplinary project team and other internal stakeholders responsible for planning and execution.
- Design History File & Technical File and set the milestones in technical coordination with the program leader and line management.
- Developing innovative medical devices or combinations products.
- Developing the device strategy, DDP, project plan, Risk Management File & Risk management Plan.
- Ensuring technical, specification, design control (DDP, URS, DIR, DO, DR, DV&V, DTx, DHF), conformity assessment (ERC/TF/DD) and risk management (RMP, RA, RMR) documentation is delivered efficiently and is aligned with the technical strategy for the combination product.
- Coaching and supervising the Device team in developing and implementing the strategy and activities associated with the device components of the combination product.
- Monitoring the progress of the project and for ensuring compliance with cost, schedule, and quality constraints.
- Undertaking proactive measures to achieve the specified goals in the event of deviations from the project plan.
- Raising awareness of critical issues and escalate to Line Function management to ensure that program lead, and management are informed in a timely manner when goals are not fully achieved.
- Recognising and justifying project spending requirements.
- Managing budget planning and for meeting agreed targets.
- Designing and developing of new products as well as product changes and enhancements.
- Performing project work streams and tasks to ensure completion according to project plans.
- Combination/autoinjector background
- Prior experience with risk management, DHF and ISO 14971
- Leadership/project management experience
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.