The main focus of the role is to lead, direct and manage the planning, execution and closure of I&D Healthcare technology led projects. Accountable for the design and development of new products for Linde Healthcare from technical feasibility, concept development, detailed design, prototyping, third party manufacturing, to product launch. The types of products will typically be medical devices.
Product Development
o To design and develop new products, specifically designed to meet the requirements as defined by the commercial, clinical and science teams within Linde Healthcare.
o To develop the appropriate documentation to support the regulatory approvals process whether by European (CE) or US (510k/PMA) routes. In alignment with the existing Quality Management System.
o To act as liaison with regulatory bodies, industry standards bodies (e.g.EIGA) and external research organisations etc. as required.
o To ensure that the design of new products is such that we are able to extract the most commercial value from the overall project by working closely with the Business Divisions & other teams (e.g. Regulatory, Marketing, I&D Business Development)
o To ensure any potential intellectual property associated with the product design etc. is secured through patenting or licensing as appropriate
o To ensure product designs are developed suitable for manufacture
o To develop detailed design transfer plans to ensure the transfer to manufacture process is smooth and efficient
o To play a key role in the identification and selection of third party manufacturers
Project Management
o To drive effective and successful delivery of the project
o To carry out project planning, and budgeting to ensure all projects are delivered on time and within budget
o To build strong working relationships with external partners such as clinicians, consultants, suppliers, manufacturers and test houses as appropriate to the project.
o To deputise for the Head of Technology as required
o To foster collaborative teamwork with the Technology Development team in Vienna and the broader I&D team
Technical Support
o To provide a strong interface between the Technology Development team & the operating divisions, so that new products are successfully brought to market and supported through launch and operation.
To provide technical input to the screening of opportunities & the preparation of business cases to obtain the necessary investment approval from management

Candidates should be able to demonstrate:

Technical competence
o Knowledge and experience of product development from concept to commercialisation.
o Experience with CAD/CAM (preferably with Pro E or Solidworks)
o Experience working in a highly regulated environment (medical, automotive) under a QMS

Impact & Influence
o Excellent communication and organisational skills
o Adopts appropriate influencing styles
o Encourages dialogue to facilitate agreement with others
o Ensures commitment to decisions from key stakeholders
o Is credible in the role and gains personal attention and respect

Other
o Self starter, capable of working without close supervision
o Comfortable with working in an ‘extended’ team environment

—They should also have:

Technical competencies around mechanical/electrical/software engineering
—Strong analytical approach
—Strong communications skills both written and oral
oLanguage skills - fluent in English
—A Technical / Engineering degree
—A significant number of years experience in a product development environment
—Medical device development experience preferred