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.
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
Requirements
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.
