Engineer/Senior Engineer (Electrical Safety, Medical Device)
Setsco Technology Center
We are seeking a dedicated Senior Engineer/Engineer to become part of our vibrant Electrical Safety team. In this role, you will be reporting to the Manager and will support clients in conducting electrical safety testing, achieving CE marking, navigating global market access, and ensuring product compliance across a range of electrical devices.
You will collaborate closely with clients throughout the testing process, helping to ensure their products meet relevant international standards while delivering exceptional communication and customer service.
Responsibilities
Perform electrical safety testing and design assessments at client sites/test labs. You will support clients in obtaining CE marking and ensuring product compliance with IEC 60601, IEC 61010 etc
You will be responsible for defining the project scope related to Life & Health Sciences and medical standards, engaging with clients to understand their technical requirements, address compliance concerns, and negotiate project timelines effectively.
You will identify and apply compliance requirements, using a pragmatic approach to investigate and resolve technical and compliance challenges. You will need to be proactive in notifying clients of compliance issues, scope changes, and provide clear communication throughout the process.
Conduct inspections as needed, compile detailed test summaries and certification reports, ensure high-quality deliverables, and resolve engineering issues related to variation notices.
Act as the primary technical liaison for clients, offering guidance on product inspections, regulatory compliance, and safety testing. Foster and sustain strong client relationships while effectively managing expectations and ensuring timely delivery of project outcomes.
Drive continuous improvement in testing procedures by recommending updated requirements and designing specialized test methods and equipment.
Function as Project Handler or Reviewer, overseeing project administration, providing client status updates, and coordinating technician activities to ensure efficient workflow management.
Any other duties as assigned by supervisor
Requirements
Bachelor's degree in Biomedical Engineering or Electrical Engineering
Proven experience in electrical safety testing and design assessments, with knowledge of IEC 60601, IEC 61010, and other relevant safety standards.
Possess client-facing experience with the ability to communicate complex technical details clearly and effectively.
Ability to manage multiple projects, ensuring timely completion and adherence to budgets.
Strong report-writing skills and attention to detail in test documentation.
Willingness to travel frequently for client site visits and inspections.
Fresh graduates are welcome to apply. We are looking for passionate self-starters with a strong willingness to learn.
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