Project Manager
2 weeks ago
TEC Partners are working with Europe's largest medical device consultancy that provides design, development, and industrialisation solutions to clients ranging from start-ups to multinational companies.
The consultancy offers design and development services at any stage of the development process, in these key areas: diagnostics, surgical, consumer and connected health, drug delivery, and MedTech. Following strict regulatory requirements, the company iscommitted to ensure the highest quality for their clients throughout the whole development process.
**Requirements**:
**Essential**
- A proven track record in the planning, management, and delivery of a broad range of healthcare development projects
- Excellent organisational, leadership and management skills
- Ability to collaborate effectively with colleagues, clients, and sub-contractors
- In-depth experience of one or more phases of the product development process (i.e.?from concept through to industrialisation and manufacture)
- Application and understanding of the requirements of key industry standards including ISO 13485, 14971 and 21CFR Part 820
- Capable of contributing to proposal preparation activity including project risk evaluation, project planning and budgeting
- Experience in managing multi-disciplinary project teams (e.g.?combining one or more of the following disciplines: mechanical engineering, electronics, software, industrial design, usability/human factors, device testing)
- Experience?in conducting?Environment,?Health & Safety risk assessments?and?COSHH assessments?as part of?project activities
- Honours?degree (or equivalent qualification/experience) in Science, Design or Engineering
**Desirable**
- Knowledge of at least one of the following markets:
- Drug delivery (injectables, inhalation or drug packaging)
- Surgical/critical care
- Diagnostics instrumentation
- Experience of technical file management and submission
- Support for business development and/or sales activities
- Understanding of project management tools (e.g.?MS Project)
- Familiar with the requirements of IEC 62304 and/or IEC 62366
- Experience in technology and supplier assessment
- Structured and methodical problem solving; ability to conduct trade-off analyses
- Ability to develop long-term client relationships
**Personal Profile**
- Confident and with a positive and engaging communication style?
- Possessing a personal style and professional/technical credibility which inspires confidence and gains the trust of clients and colleagues
- A self-starter who can manage their own time and workload, copes well with unexpected change; is flexible and calm under pressure
- Displays honesty and integrity at all times
- Willing to take responsibility and drive projects to a successful outcome
- Respects?others' views, opinions and contributions, and is supportive of colleagues?
- Collaborates effectively; a good team player, aware of own limitations and recognising the strengths of others
- Shows an eagerness to continually learn and drive best practice
- Willing to travel, entertain clients and is well presented
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