System Development Engineer (Medical Device-FDA/MDD/MDR)
The Product Development Engineering Specialist is a critical Engineering role involved in 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. This 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
Qualifications and Experience:
- Bachelor degree in Engineering
- Minimum 1-3 years of product design or engineering experience in product development environment.
- A good understanding of product life-cycle engineering
- Preferably with basic knowledge in medical device regulations for US FDA, EU MDD/MDR.
- Formal training in project management, experiment methodology, Six Sigma, DFSS, etc. will be added advantage.
- Demonstrates good knowledge of regulations and customer specifications and their impact on design parameters
To apply, please click "Apply Now" or visit www.gmprecruit.com and search for job reference: 17124
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Tan Wai Peng | Registration No: R110467
GMP TECHNOLOGIES (S) PTE LTD