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£Neg+ Car/Allowance + benefits
The purpose of this position is to lead, direct and manage the planning and execution of all technical lead activities on product development projects, principally medical devices. Our client is a global Healthcare organisation and you will responsible for leading engineers from numerous different disciplines (mechanical, electronics, software etc.), including outsourced partners.
Design and development of new products, specifically designed to meet the requirements as defined by the commercial, clinical and science teams.
Liaison between marketing, customers and the technical development team.
Where appropriate take accountability for the system architecture of more complex devices.
Facilitate product risk analysis and identify necessary mitigations.
Facilitate the prioritisation between contradicting requirements to generate one requirements document per product or product range.
Facilitate good technical decision making in terms of concept selection, executing meaningful feasibility studies and selection of key components, subsystem elements and solutions.
Where appropriate deploy statistics to characterise the design (for example sensors).
Requirements management throughout the development process including traceability to verification and validation evidence.
Co-ordinate design review activities.
Co-ordination and in part writing of the Design History File throughout development.
Assist the development team in a functional breakdown of the devices under development.
Assist in planning the projects, including verification activities.
Assist in establishing a requirements management tool
Assist in establishing a requirements management process.
Issue tracking and resolution.
Participate in audits.
Maintain awareness of new and emerging technologies and the potential application within the organisation.
The project manager of the product development project (both the system engineer and project manager) are likely to work with the same core team at any time, but form different aspects. The project manager facilitates a timely, to budget product development, whilst the system engineer works with the same team for effective technical decision making. At times there is significant overlap, so continuous communication is required.
External Development Partners.
Commercial Development (I&D).
Working with the Healthcare Global marketing and regional business divisions who will ultimately commercialise any I&D ‘concept’.
Work with external health personnel and business management to identify the required product and system specifications to maximise product adoption and use.
Required critical behaviours:
Business acumen, Strategic thinking, Customer focus, Change leadership, Functional and technical competency,
Decision making and execution, Process, project and risk management, Cross cultural communication and collaboration, Negotiation and conflict resolution.
Comfortable in spanning numerous engineering disciplines (mechanical, electronics, software etc.)
Strong analytical approach.
Balanced between methodical approach and efficiency (to make good use of team’s time).
Language skills: Fluent in English, German is a plus. (Other language also beneficial).
Degree qualified.(Engineering or related technical).
10 years plus exp. in product development, of which 5 years in medical device development (preferred), or other regulated industry experience (essential).
5 years exp. leading technical development activities.
Exp. with outsourced development (contracts, timelines etc.), manufacturing.
Exp. over the entire product development lifecycle (from conception to manufacturing).
Exp. in working with international teams.