R&D Process Development Manager

NHL/APJW-134701

R&D Process Development Manager

The R&D Process Development Manager will develop process technology for new products through a combination of in-house prototyping and working with external suppliers.


The role will ensure Design for Manufacture (DFM) considerations are captured from the early concept stage and develop a roadmap that balances time to market with long term volume manufacturing requirements.


Overall responsibility for technical aspects of early process development for new product development projects, including process specification generation and identification of optimal solution through process development.

Responsibilities:

• Provide leadership to the team in the development of new processes, building and testing of prototypes, testing, data analysis and interpretation, component and finished device assembly drawings/specifications, product materials selection, and process development.
• Advise the design team on how process influences new concepts.
• Ensure DFM is considered at the concept stage.
• Working in conjunction with internal and external manufacturers, complete process characterization studies.
• Support process validation, ensuring process capabilities are achieved.
• Achieve continuous improvement prior to commercial handover through data driven decision making and make an impact.
• Support design of new products, optimisation of product performance and refinement of product design to meet technical specifications through process development.
• Identify and manage key technical process development project risks and appropriate mitigations.
• Identify and select product materials and assembly methods.
• Identify, acquire, and commission equipment for in-house capability development.
• In conjunction with the project lead, identify a process development strategy for each R&D project determining which aspects of the project to perform in-house and outsource.
• Commission process development work with internal or external manufacturer.
• Build and test prototypes, analyse test data and interpret to identify optimal solution(s).
• Write and/or review procedures, protocols, specifications, and reports.
• Translate needs requirements into technical specifications.
• Leverage and liaise with external resources to support achieving project goals.
• Foster a culture of creativity; generate creative product solutions to address unmet needs.
• Support generation of Intellectual Property by filing new ideas and drafting patents as required.
• Manage engineer(s) and/or technicians for equipment commissioning, validations, maintenance, and process development studies.
• Manage technical project resources as required, including responsibility for goal setting, performance reviews, identify and support development needs.
• Perform other duties as assigned or required.

• Honours degree in Mechanical or Biomedical Engineering or equivalent.
• A minimum of 10 years’ experience in medical device industry with experience of technical leadership, and prior product development experience as a Senior R&D Engineer is required.
• People management experience.
• Strong technical leadership capability in the development of new processes for new products, generates creative product solutions to address unmet needs.
• Excellent technical problem solving and analytical ability.
• Strong catheter design, process development and technical ability is essential, based on a solid foundation of fundamental engineering principles. Strong work ethic and creative problem solver.
• Data review and statistical methods expertise (Minitab).
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience. Desirable
• Creative problem solver.
• Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
• Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments.