Total 2 job vacancies by Sg Endoscopy Pte. Ltd.

JOB RESPONSIBILITIES

· Develops and conducts test plans and protocols for design verification, process characterization, process validation, finished product and benchmarking study to generate test reports with sound engineering principle.

· 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.

· Participate in Risk Management and Failure Analysis exercises such as FMEA (Failure Mode & Effects Analysis).

· 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.

JOB REQUIREMENTS

· Degree or Masters in Mechanical/Electrical/Bio Engineering or related field

EXPERIENCE

· Minimum 3-5 years relevant experience, preferably in Medical Device, Automotive or Aerospace industry.

· Knowledge and familiar with IEC60601 test and requirements.

SKILLS

· Strong in mechanical and electrical fundamentals.

· Good understanding of DOE (Design of Experiments) principles.

· Prefarably with six sigma green belt training

JOB RESPONSIBILITIES

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.

• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.

• Completes design and development projects by training and guiding technicians.

• Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing processes and solutions during project development.

• Participates in Design for Manufacturing and Assembly study with Design Engineers.

• Participates in Design Review, Design Verification, dFMEA, pFMEA and aFMEA activities.

• Design fixtures based on output of dFMEA activities.

• Perform other tasks as assigned by the supervisor.

JOB REQUIREMENTS

• Degree, MSc or PhD in Mechanical, Electrical or Biomedical Engineering.Technical Diploma with minimum 5 years in Medical Device Development.

EXPERIENCE

• At least 2 years of experience in the medical device industry including concept definition, prototype manufacturing, prototype testing and design documentation.

• Technical Diploma with minimum 5 years in Medical Device Development.

• Experience in simulation software (Abacus, CREO Simulate, etc.).

SKILLS

• Excellent command of Computer Aided Software (CREO, Solidworks or equivalent).

• Strong knowledge of technical standards (ASME, JIS, etc.).

• Competent in data analysis tools like DOE, Minitab.

• Strong command of English (Written and Oral).

• Strategic thinking.

• Resourceful and innovative.

• Independent and has the ability to work under pressure.

• Able to work cross-functionally to develop specific plan to address different challenges.