Client Background: Medical device manufacturing

Tenure: Permanent

Location: Batu Kawan, Penang

Headcount: 1

Job Responsibilities

• Apply project management principles to plan, track, execute, and report project status
• Develop product requirements
• Review electrical, mechanical, and optical designs and changes to ensure appropriate test method development
• Define strategies and perform product design and testing to comply with electrical safety standards and medical device regulations
• Develop and execute test methods and fixtures for design verification
• Define and execute test plans to support design verification
• Work closely with Mechanical, Electrical, and Optical Engineers to develop opto-electromechanical test methods
• Provide electronic and system-level troubleshooting of prototype devices to support product development
• Act as a hands-on engineer to troubleshoot new product or process issues related to design, material, or process
• Conduct feasibility studies to verify capability and functionality or assess existing technologies
• Solve complex problems and make sound design recommendations
• Summarize, analyze, and draw conclusions from complex test results
• Prepare complex reports and communicate results to a wide range of audiences
• Maintain and manage engineering documentation
• Proactively build relationships and collaborate with cross-functional partners to ensure technical deliverables meet stakeholder needs
• Identify and build relationships with external device manufacturers

Job Requirements

• Bachelor’s degree in Biomedical Engineering, Electrical Engineering, or related field (Computer, Software, Systems)
• Minimum 8 years of experience in product development
• Strong proficiency in systems engineering principles
• In-depth knowledge of design verification in a regulated industry
• Proficient with lab equipment such as power supplies, oscilloscopes, multimeters, spectrum/signal/logic analyzers
• Strong written and verbal communication and presentation skills
• Experience working within Design Controls or equivalent in the Medical Device industry
• Knowledge of electrical safety (IEC 60601-1), HF (IEC 60601-2-2), and EMI/EMC (IEC 60601-1-2) standards
• Willingness to travel 10–20%, including international travel
• This position is an additional headcount

Preferred Qualifications

• Medical device industry experience
• Master’s or PhD in Biomedical Engineering, Electrical Engineering, or related field
• Clinical and technical knowledge of imaging-based medical devices
• Strong knowledge of electrical engineering, optics, and bio-instrumentation principles