Working within the Research and Development Group and across all functions within the manufacturing organisation to deliver product development projects on time, within budget and to agreed quality, following business development strategy for medical devices.
- Plan and manage the projects so as to meet Product time-to-market and cost targets to the agreed standards
- Lead, manage and motivate the Project Team to ensure that products are planned, implemented, released and supported consistent with the agreed standards and strategy and risks are identified and managed
- Present regular progress reports, and to escalate any issues for resolution to Senior Management
- Work with the Project Teams to achieve Stage Gate Reviews in accordance with Product Development Process (KMP 0200)
- Ensure products meet new appropriate safety standards
- Ensure that all members of the Project Team (as defined in the PDP) are defined
- Ensure that all team members are fully competent to complete the projects
Qualification & Experience
Certificate(s)/Degree in Engineering or Technology Management related disciplines, or equivalent.
Professional qualification in project management e.g. Membership of APM, Prince II practitioner, PMP
Applied knowledge of:
- Product Design and Development
- Medical Device development (preferred)
- Relevant regulatory standards - ISO9001 (mandatory), ISO13485, ISO14971, ISO60601, ISO61010, ISO62366 (preferred)
- Relevant regulatory directives and requirements - US and EU medical directives, RoHS, WEEE, China and Japan medical directives, EMC, LVD (preferred)
- Software development (preferred)
- Microsoft Office and Product Data Management (PDM) systems
- Programme management (preferred).
Proven experience of:
- Project manager/leader with at least 3 years R&D/new product development project management experience with track record of delivery
- Excellent communication and presentation skills; confident in front of project teams and senior management
- Strong leadership, team coach and facilitator, a builder and empower of people
- Proficient in the use of related tool (e.g MS Office, PowerPoint, Project)
- Generating ideas and selecting the best way forward according to requirements
- Problem solving
- Industrial - Development of Industrial / Video Devices (preferred)
- Medical - Development of Medical Devices (preferred)
- Working in a highly regulated and audited environment
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