Plexus is proud to be known as a Product Realization Company, with more than 30 years of experience in turning customers' concepts into world-class products through our unique set of value-added Product Realization Solutions. Plexus currently supports a variety of market segments including Networking & Communications, Medical/Life Sciences, Industrial / Commercial, Defense / Security / Aerospace.
Penang Design Center
Penang Design Center is the centerpiece of Plexus Engineering Solutions Group presence in Asia Pacific. We are currently expanding and looking for dynamic, talented and innovative individuals to be part of our design team developing state-of-the-art products for our customer.
You will be responsible for the next-generation platforms for our business partner in Wireline/Wireless Networking Infrastructure, Medical, Industrial/Commercial, Defense/Security/Aerospace market sectors.
• Identify and document product specifications related to safety agency and regulatory requirements (UL, CE, FDA, FCC, etc.) including functional, electrical, mechanical and labeling specifications as well as mentor and lead the project team on safety agency and regulatory items.
• Lead product Risk Analysis and mitigation development efforts to confirm the design team has accurately identified product hazards, assessed the level of risk for each hazard and applied mitigation; maintaining the Risk Analysis throughout the project to ensure that hazards are assessed as the design evolves.
• Lead Design Failure Modes and Effects Analysis (compile and maintain the necessary supporting documentation) to ensure the success of the project.
• Lead Product Reliability Assessments to develop requirements and protocols to verify product reliability
• Coordinate design verification test activities through the development and maintenance of verification test plans, procedures and reports to ensure verification prototypes meet design requirements and confirm effectiveness of hazard mitigations.
• A minimum of a(n) Bachelor's degree in Engineering or equivalent experience is required.
• Experience of 4 year(s) is required for this position, assuming education requirements are met. Equivalent industry experience of 4 or more year(s) is highly desirable.
• Possess expert knowledge of the FDA Quality System Regulation.
• Possess expert knowledge of ISO13485.
• Possess moderate knowledge of ISO14971.
• Possess moderate knowledge of IEC/UL 60601-1 and collateral standards.
• Possess moderate knowledge of IEC/UL 61010-1 and collateral standards.
• Possess understanding of Risk Analysis process, Failure Modes and Effects Analysis process, Fault Tree Analysis, and Requirements and Hazard Traceability processes.
• Possess moderate knowledge of medical software development life-cycle process and requirements.
• Possess moderate knowledge of EU Medical Device Directive.
• Possess moderate knowledge of EU In-Vitro Diagnostic Directive.
• Possess knowledge of EU Active Implantable Medical Device Directive.
• Possess knowledge of the FDA 510(k) and PMA submittal process.
• Ability to multi-task.
Type : Company job
Role : Senior Executive
Industry : Electrical & Electronics
Salary : Not Disclosed
ABOUT PLEXUS-Plexus (www.plexus.com) has delivered optimized Product Realization solutions through a customer focused service model since 1979. This service model seamlessly integrates product conceptualization, design, commercialization, manufacturing, fulfillment and sustaining services to deliver comprehensive end-to-end solutions to customers in the America, European and Asia Pacific regions. Our flexible business model enables customers to choose any combination of services to realize their go-to-market strategies while focusing on their core competencies. Plexus offers services to over 100 branded product companies in the Defense/Security/Aerospace, Industrial/Commercial, Medical, Networking/ Communications sectors.
PENANG DESIGN CENTER
Penang Design Center is the centerpiece of Plexus Engineering Solutions Group presence in Asia Pacific. We are currently expanding and looking for dynamic, talented and innovative individuals to be part of our design team developing state-of-the-art products for our customer.You will be responsible for the next-generation platforms for our business partner in Wireline/Wireless Networking Infrastructure, Medical, Industrial/Commercial, Defense/Security/Aerospace market sectors.