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Lead Medical Device Engineer

2 months ago

Singapore PASONA SINGAPORE PTE. LTD. Full time
About the Role

We are seeking a highly skilled and experienced Medical Device Lead to join our team at PASONA SINGAPORE PTE. LTD. as we continue to drive innovation in the field of electrocardiogram (ECG) systems.

Key Responsibilities
  • Lead the Development of ECG Medical Devices
    • Oversee the end-to-end development of ECG medical devices, from initial concept and design to testing, validation, and market launch.
  • Collaborate with Cross-Functional Teams
    • Work closely with clinicians, engineers, and product managers to define product specifications and ensure alignment with clinical needs and regulatory requirements.
  • Ensure Regulatory Compliance
    • Ensure compliance with medical device regulations (such as FDA, CE, ISO) and prepare all necessary documentation for regulatory submissions.
  • Manage Risk Analysis and Quality Control
    • Manage risk analysis, quality control processes, and testing protocols to ensure device safety and reliability.
  • Lead Collaboration with External Partners
    • Lead the collaboration with external partners, including suppliers, testing laboratories, and certification bodies, to ensure the device meets global standards.
  • Stay Current with Medical Technology Advancements
    • Stay current with advancements in medical technology and ECG innovations, incorporating the latest scientific research into the product development process.
  • Mentor and Manage a Multidisciplinary Team
    • Mentor and manage a multidisciplinary team of engineers, providing guidance and fostering an environment of continuous improvement and innovation.
Requirements
  • Minimum 5 Years of Experience in Medical Device Development
    • A minimum of 5 years of experience in medical device development, with a focus on ECG devices or other diagnostic equipment. Proven track record of taking medical devices from concept to market is highly valued.
  • Strong Background in Biomedical Engineering or Electrical Engineering
    • Strong background in biomedical engineering, electrical engineering, or a related field. Experience with ECG signal processing, device hardware design, and software integration is essential.
  • In-Depth Understanding of Medical Device Regulations
    • In-depth understanding of global medical device regulations (e.g., FDA 510(k), CE marking, ISO standards) and experience with regulatory submissions and compliance processes.
  • Leadership and Project Management Skills
    • Demonstrated ability to lead complex projects, manage cross-functional teams, and coordinate with external stakeholders to deliver high-quality medical devices on time and within budget.
  • Strong Analytical and Problem-Solving Skills
    • Strong analytical and problem-solving skills, with a proactive approach to identifying issues and developing solutions in the development process.
  • Rigorous Attention to Detail
    • Rigorous attention to detail in the design, testing, and documentation of medical devices to ensure they meet the highest standards of safety and efficacy.
  • Excellent Communication and Teamwork Skills
    • Excellent communication and teamwork skills, with the ability to work effectively across departments and with external partners.
  • Passion for Medical Technology Innovation
    • Passion for medical technology innovation, with a desire to push the boundaries of ECG device capabilities to improve patient outcomes.
  • Relevant Education and Certifications
    • Bachelor's or master's degree in biomedical engineering, electrical engineering, or a related field is required. Advanced degrees or certifications in medical device design or regulatory affairs are a plus.