Regulatory Affairs jobs in Singapore
Senior Research & Development Engineer
MASS POWER SERVICES PTE. LTD.
Project Manager (A&A, Workplace Office)
ALWAYSHIRED PTE. LTD.
Global Field Service Engineer – Pumps & Laser Alignment
SVANEHOJ SINGAPORE PTE. LTD.
Temporary Administrative Executive
CULTIVAR ASIA PTE. LTD.
Product Tanker Marine Superintendent - Safety & Compliance
COENS ENERGY PTE. LTD.
Discover more opportunities than anywhere else. Find more jobs nowGeneral Manager
SINGAPORE DAZHONG MINING INTERNATIONAL TRADING PTE. LTD.
Senior Technical Lead – Avaloq (12 months contract)
ESOL PTE. LTD.
Senior Safety Policy & Risk Management Specialist
BUSINESS EDGE PERSONNEL SERVICES PTE LTD
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COLUMBIA SHIPMANAGEMENT (SINGAPORE) PTE LTD
Senior Marine Superintendent - Safety, Compliance & Inspections
COLUMBIA SHIPMANAGEMENT (SINGAPORE) PTE LTD
Accountant, GL (US MNC)
MICHAEL PAGE INTERNATIONAL PTE LTD
Marine Superintendent
COLUMBIA SHIPMANAGEMENT (SINGAPORE) PTE LTD
Senior Project Specialist (Safety Policy & Consultancy Study)
BUSINESS EDGE PERSONNEL SERVICES PTE LTD
KYC Specialist | Contract
MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD
Senior Technical Lead – Avaloq
CORNERSTONE GLOBAL PARTNERS PTE. LTD.
Manager, Senior Manager (equivalent to Technical Superintendent, Senior Superintendent)
MARUFLEET MANAGEMENT PTE. LTD.
Corporate Secretarial Executive
DURBAR RESTAURANT PTE. LTD.
Senior Research & Development Engineer
Job summary
A leading medical device company in Singapore is seeking an experienced professional to develop and maintain innovative medical device products. The role requires a Degree or Master in Mechanical Engineering, along with at least 5 years of experience in the medical device industry. Responsibilities include driving product design based on customer needs, managing project timelines, and ensuring compliance with medical standards. Candidates should possess strong mechanical design skills and effective communication abilities. Join our team to impact healthcare positively.
Qualifications
- Minimum 5 years working experience in the medical device industry.
- Experience with medical instruments or active medical devices.
- Familiar with ISO 13485 or FDA QSR design control.
Responsibilities
- Develop new Medical device product design based on customer needs.
- Maintain existing Medical device products based on customer feedback.
- Drive continuous improvements on product cost, quality, and delivery.
Skills
Education
Tools
- Develop new Medical device product design based on customer needs, project management and support related DHF creation.
- Maintain the existing Medical device products based on customer feedback and internal inputs.
- Technical support, work together with cross-functional teams to drive continuous improvements on Medical device product cost, quality and delivery.
- Assist on project management during new Medical device product design.
- Develops and conducts test plans and protocols for design verification, process characterization, process validation, finished product and benchmarking study to generate test reports with engineering principle.
- Manage R&D prototype and testing lab, participate prototype & testing lab budget management.
- Maintain the equipments and tools and monitor regular required calibration, qualification.
- Design, develop, and implement automated and manual test procedures for functional, performance, and regression testing.
- Identifies and consolidates requirement lists from product performance, functional and regulatory aspects
- Drives the entire design verification and validation activities to ensure compliance to regulatory requirements such as IEC, FDA, GMP, ISO and IEC standards.
- Develops and executes various benchmark testing to understand product quality compared to existing products
- Develops and validates new equipment and fixtures to conduct various testing.
- Conducts feasibility testing together with product development and quality team
- Liaise with external test labs to obtain critical data for test reports.
- Work with equipment vendors to identify test equipment that meets testing requirements.
- Identify, document, and track defects using issue tracking tools.
- Work closely with development teams to identify and address potential issues early in the development lifecycle
- Communicate all identified risks to your Test/Team Lead
- Summarizes test report and present to project and management team.
- Perform other tasks as assigned by the supervisor.
- Other tasks assigned by superior
- Degree or Master in Mechanical Engineering, Electrical or Material Science.
- Minimum 5 years working experience in medical device industry, executed new product development progress and project management.
- Be experienced with medical instruments or active medical device, be competent with mechanical structure design, complex plastic parts structure design, and understand the related medical standards.
- Good cross department communication and collaboration;
- Creo modelling skills and innovative product design capability.
- Mechanical structure design competence including plastic design, metal part design,etc for Medical device use.
- Be familiar with ISO 13485 or FDA QSR design control.
- Be familiar with plastic injection molding process, metal machinery process.
- Problem Solving and self-motivate.
- Working location at Tampines Area
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.