- Develop product engineering requirements and guiding architectural design to ensure that products meet customer and business expectations for safety, regulatory, quality, performance, functionality, reliability and efficacy.
- Involves defining processes for technical platforms, system requirements, input/output and working parameters for hardware and/or software compatibility.
- Systems Engineering conceives system interfaces within the device and considers implications with interfacing to business applications. This includes identifying, analyzing and resolving system design weaknesses.
- Build productive internal/external working relationships to ensure that the system objectives are balanced with overall project objectives.
- Define design structure to provide desired functionality per product and user requirements and Medical Device Regulatory (MDR) Standards for applicable regions.
- Identify, define and communicate compliance requirements for all aspects of projects. Develop measures, feedback and reporting mechanisms for Senior Management.
- Occasionally leads the work of project teams and might formally train junior members.
- Manage and contribute to new/existing projects and provide advice/direction in primary areas of expertise where possible.
- Leveraging professional expertise and relationships to contribute to drive business strategy and results
- Bachelor degree in Engineering
- A minimum of 1 to 3 years of product design or engineering experience in product development environment.
- Preferably with basic knowledge in medical device regulations for US FDA, EU MDD/MDR.
- Formal training in project management, experiment methodology, Six Sigma, DFSS, or other related engineering topics will be added advantageous.
- Demonstrates good knowledge of regulations and customer specifications and their impact on design parameters (i.e. marketing, clinical, regulatory, manufacturing, quality, IP).
- Candidate must be willing to commit the full 1-year contract duration.
To find out more about this opportunity, please contact Lionel Liew at email@example.com.
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Lionel Liew | Registration No: R1330693