Highlight:
- Japan MNC
- Permanent job opportunity
- Great remuneration & benefits
- Great career progression
- Experience in R&D for class 3 medical device is a major advantage.
Responsibilities
- Lead the end-to-end development of ECG medical devices, from initial concept and design to testing, validation, and market launch.
- Collaborate with clinicians, engineers, and product managers to define product specifications and ensure alignment with clinical needs and regulatory requirements.
- Oversee the integration of hardware and software components to ensure the ECG devices meet performance, safety, and usability standards.
- Drive the design of user-friendly interfaces and workflows that enhance the clinical application of ECG devices.
- Ensure compliance with medical device regulations (such as FDA, CE, ISO 13485) and prepare all necessary documentation for regulatory submissions.
- Manage risk analysis, quality control processes, and testing protocols to ensure device safety and reliability.
- Lead the collaboration with external partners, including suppliers, testing laboratories, and certification bodies, to ensure the device meets global standards.
- 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 of engineers, providing guidance and fostering an environment of continuous improvement and innovation.
Requirements:
- Experience: 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.
- Technical Expertise: Strong background in biomedical engineering, electrical engineering, or a related field. Experience with ECG signal processing, device hardware design, and software integration is essential.
- Regulatory Knowledge: 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.
- Project Leadership: 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.
- Problem-Solving: Strong analytical and problem-solving skills, with a proactive approach to identifying issues and developing solutions in the development process.
- 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.
- Collaboration: Excellent communication and teamwork skills, with the ability to work effectively across departments and with external partners.
- Innovation-Driven: Passion for medical technology innovation, with a desire to push the boundaries of ECG device capabilities to improve patient outcomes.
- Education: A 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.
HOW TO APPLY:
Interested applicants, please send your latest resume to [email protected] or click on “Apply Now” and provide the below details in your resume.
- Last drawn salary
- Expected salary
- Notice period
- Reason of leaving
We regret only shortlisted candidates will be notified.
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