Senior R&D Project Manager
Medical Devices Manufacturer based in Cambridge seeks an experienced Senior R&D Project Manager
Duties may include:
- Project management of key R&D product development projects, the typical products being developed are complex medical devices involving mechanics, electronics, software and chemistry.
- Deliver the projects to key business objectives to the required quality, cost and time-scale
- To establish and effectively communicate 'shared targets' of projects and then subsequently manage those projects to delivery.
- To monitor and communicate progress. To take proactive action to minimise the risk of 'overrun'.
- Lead the Risk Management Process
- Lead the project team through delivery milestones by working with key stakeholders as well as doing hands on work to complete documentation deliverables for the Quality Management System (QMS).
- Contribute to System Engineering
- Manage the Product Requirements Traceability
- Contribute to the development of the company's Project Management systems
- Tracking of resource allocation on project related and non-project related activities.
- Works closely with Development, Operations, Quality, Marketing, Regulatory and other departments to ensure project priorities and decisions are consistent between teams and corporate strategic plans.
- Working with colleagues in Quality and Regulatory to ensure the processes we use meet all quality and regulatory requirements, but also are lean and efficient for our business
Skills and experience:
- Expert in medical device product development from initial concept through to production and the interdependencies of individual development activities.
- Working knowledge of basic scientific and engineering principles
- Working knowledge of regulatory requirements for product registration on global basis
- Creation, management and reporting of product development plans in association with the appropriate company functions. Revision of those plans as appropriate to meet changing needs
- Working with technical and commercial staff on internal and external development projects
- Working with external clients in order to manage their expectations against delivery
- Project planning in the form of Gantt charts, milestone trackers, projected budget, etc,
- Working knowledge of typical software packages such as Microsoft Excel and MS Project
- Project related financial management
- Proven negotiation, issue resolution and team building skills
- Excellence in communication, stakeholder management, facilitating and managing meetings
- Expert in facilitating team decision making
- Ability to encourage intelligent risk taking and a bold culture
- BSc Degree or equivalent qualification in mechanical, electronic, or biomedical engineering
- A member of a recognised institute of project management is desirable.
- Highly experienced in designing complex medical devices from initial design concept through to production
- Experience with project management in a complex multi-disciplinary environment, from concept to delivery
- Experience in healthcare is required with familiarity working in regulatory environments.
- Delivering projects to challenging timescales
- Working with cross functional groups
- Experience with ISO 13485
- 5+ years' experience in the role