Senior System Engineer, Medtech Catapult

3 days ago

Singapore NodeFlair Full time

**Job Summary**:
**Salary**
S$5,950 - S$11,900 / Monthly

**Job Type**

**Seniority**

Senior

**Years of Experience**
At least 5 years

**Tech Stacks**
MODE

The MedTech Catapult has a dedicated objective of curating and accelerating the development of high potential MedTech projects through an in-house product engineering unit. This productization unit is responsible for supporting the development of technologies through the medical device development cycle to produce full-fledged hardware product systems. The Senior System Engineer will report to the Principal Engineer.

**Responsibilities**:

- Support systems engineering efforts for complex medical solution
- Supporting and reporting on all phases of the product development and operations lifecycle including hardware assembly and integration, software builds, loads and updates, configuration control, requirements, design, and test execution.
- Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF).
- Support the development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical documentation.
- Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed. Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
- Provide technical guidance for product design, development, integration, testing, and reliability improvements.
- Owns and drives resolution of design issues/defects
- Works with QA team to specify and document product tests for compliance to regulatory standards.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Write and review documentations for QMS.
- Design risk analysis, risk management, Verification and Validation procedures.
- Interface with external parties (design houses) to communicate product requirements, and subsequent knowledge transfer to build internal capability
- Supplier development
- To support other operational activities of the Programme Office

**Requirements**:

- Bachelor's degree in System Engineering, Electro-mechanical engineering or relevant degree in a related field
- 5 years experience in medical devices (e.g. hardware, connected devices) managing product design and development, with hands-on experience in system architecture and integration of mechatronic systems
- Extensive knowledge in software and system integration
- Experience managing QMS and proficient with GMP guidelines and regulations which include managing system verification and validation
- Good collaboration skills, organised and detailed
- Demonstrate strong interpersonal skills and leadership skills

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