Principal R&D Engineer
4 weeks ago
Job Summary:
The Principal Engineer will be responsible for providing technical leadership in the design and development of complex R&D projects from early stage to commercialization. Overall responsibility for technical aspects of new product development projects, including product specification generation and identification of optimal solution through design development and characterization, technical risk management and test capability development. The responsibilities and the impact YOU will have:- Manage the onsite engineering team through technical tasks.
- Support and coordinate external design partners and suppliers through the design process and represent technical needs throughout the project.
- Coordinate with the cross-functional team to ensure quality/regulatory/supply chain needs are communicated and met.
- Design and manage animal studies with the support of the clinical team.
- Communicate technical advances and challenges to the wider R&D Team and leadership.
- Provide technical leadership and take ownership of critical technical tasks in the execution of product development projects.
- Optimise product performance and refine product design to meet technical specifications.
- Identify and manage key technical product development project risks and appropriate mitigations.
- Develop test capability to evaluate product performance and safety requirements.
- Identify and select product materials and assembly methods.
- Build and test prototypes; analyse test data and interpret to identify optimal solution(s).
- Write and/or review procedures, protocols, specifications, and reports.
- Liaise with key opinion leaders to develop a deep understanding of the disease state, gather user needs; and articulate throughout the team.
- Translate needs requirements into technical specifications.
- 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.
- Performs other duties assigned as needed.
Qualifications:
We would love to hear from YOU, if you have the following essential requirements:
- Honours degree in Mechanical, Electrical, or other related Engineering field.
- 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.
- Strong understanding of engineering principles including complex fluid dynamics.
- Engineering experience in either electrical, electro-mechanical medical products and components or equipment.
- Engineering experience as part of a team developing software and embedded design.
- Excellent technical problem solving and analytical ability.
- Experience of intellectual property generation and filing.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
- Knowledge and demonstrated application of regulated medical device development processes, standards, and guidelines, including but not limited to ISO 13485, ISO 14971, and IEC 60601.
- Statistical Analysis knowledge (e.g., Design of Experiments (DOE)).
- Knowledgeable about medical-specific assembly technologies, the equipment supplier base, and the capabilities of the suppliers.
Experience in Design for Manufacturing or Assembly.
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This position was p P osted on 21 Mar 2024
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