Senior Compliance Engineer

Responsibilities:

• Responsibility for achieving global product compliance in the areas of product safety, Electromagnetic Compatibility (EMC), Wireless, RoHS, EU REACH Regulation, and other compliance.
• Work with cross functional team (R&D, Operation, QA, Supply Chain) and external agencies in delivering a new product or sustaining product that meets various world-wide regulatory standards.
• Work closely with global TUV SUD, UL or similar test & certification agency for ensuring life sciences instruments or medical devices meet the global product compliance standards.
• Be involved actively in all design review phases for new products or sustaining products; and provide compliance feedback to the cross functional team. 
• Generate and release compliance test plan and test report. 
• Involves in troubleshooting new products or sustaining product in EMC area and provide recommendations to cross functional team.
• Involves in recommending safety critical components and prepare document to submit to TUV SUD, UL or equivalent product safety agency.  
• Be proactive in anticipation of new compliance changes that may impact design instrument and compliance test requirements. 
• Be proactive in maintaining certifications in response to standard change or compliance changes and update the changes to the management and cross functional team. 

Requirements:

• Bachelor’s degree in Electronics/Electrical/Electromechanical/Mechatronics Engineering or equivalent.
• Minimum 5 years’ experience in life sciences’ General Laboratory Equipment (GLE) or Medical Device industry is preferred.
• Knowledge in digital/analog circuit, AC circuit, AC component, and power supply.
• Knowledge of global product safety (IEC/EN/UL 61010-1 and sub-particulars) or similar, EMC (IEC/EN 61326-1, IEC/EN 61326-2-6, FCC, ICES) or similar, global RoHS, EU REACH Regulation, WEEE Directive, and Battery Directive.
• Positive learning attitude, growth mindset, and committed.
• Require travelling abroad.