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, analysing 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
Minimum Bachelor Degree in any relevant Engineering field
At least 1 - 3 years of product design or engineering experience in product development environment preferably in Medical Devices/Aviation/Automobile industries
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, 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 time 1-year contract duration
To apply, please visit to www.gmprecruit.com and search for Job Reference:17125
To find out more about this opportunity, please contact Alexandra at: email@example.com
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: R1101491