- Perform design improvements to our existing products, in areas of electrical/electronic and pneumatic systems.
- Conduct bench test, perform design verification and validation of design in accordance with ISO 13485 and applicable regulatory requirements.
- Lead transfer of product design to contract manufacturer in areas of assembly, manufacturing, test, quality and cost.
- Troubleshoot issues, provide design solutions, verify and validate solution and coordinate implementation.
- Liaise and manage contract manufacturer and production processes, ensure consistent quality conforming to medical device standards. Involve in the design and fabrication of jigs and fixtures for production assembly and test.
- Perform supplier sourcing and qualification for assembly/sub assembly/part.
- Perform risk assessment for design and process, drive recommended action to closure.
- Possess ownership of engineering documentation as per SOP
- Perform other tasks as required to meet project timeline and objective.
- Bachelor's Degree qualifications in electrical & electronics engineering, biomedical, mechanical, or related engineering fields
- Minimum 3 years' experience in product design modification and improvement for the medical device industry
- Knowledge of medical device regulatory, ISO13485, IEC62304 standards
- Some knowledge of microcontrollers and embedded firmware application will be advantageous.
- Experience in manufacturing preferred
- Initiative, self-motivated and able to work independently in the defined scope of work.
- Company objectives driven mindset, with company shares allocation based on performance.
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Senior/Product Engineer - Singapore - TRENDLINES MEDICAL SINGAPORE PTE. LTD.
4 days ago
Description
Roles & ResponsibilitiesTrendlines Medical Singaporeoperates through investing in, incubates, and provides a range of critical services to nurture and support Singapore-based entrepreneurs and start-up companies in the medical device sector from development to commercialization in the global market.
We are looking for Senior/Product Engineer (Medical Devices) to join one of our portfolios located in Singapore. More about us and our portfolios:
Roles & Responsibilities:
Skills & Requirements:
Risk Assessment
Product Design
ISO
Electrical
Fabrication
Project Timeline
Firmware
Medical Devices
Microcontrollers
Commercialization
Regulatory Requirements
Assembly
Manufacturing
Electronics
Able To Work Independently