Job ID: 19248
- Location: Buona Vista/ Commonwealth/ One North
- Working hours: 9am - 6pm
- Salary: up to $12,000 (Depending on experiences)
Job Description
We are seeking an experienced and driven Lead Medical Device Engineer to oversee the development of cutting-edge ECG (electrocardiogram) systems as part of our rapidly growing healthcare division.
In this role, you will lead the design, development, and regulatory approval of state-of-the-art ECG devices that meet the highest standards of medical safety and performance. You will work closely with cross-functional teams, including clinical experts, product managers, and regulatory affairs specialists, to bring groundbreaking products to market. Your leadership and technical expertise will be key to driving innovation and ensuring our devices improve patient care globally.
- 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.
Job Requirement
- 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, electrical engineering, or a related field. Experience with ECG signal processing, device hardware design, and software integration is essential.
- 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.
- 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, with a proactive approach to identifying issues and developing solutions in the development process.
- 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, with the ability to work effectively across departments and with external partners.
- Passion for medical technology innovation, with a desire to push the boundaries of ECG device capabilities to improve patient outcomes.
- 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.
Interested applicants, kindly send your updated resume to Joanne (R21101135) [Confidential Information] with the email subject header Job Application for 19248, Lead Medical Device Engineer.
Only shortlisted candidates will be notified, other applications will be updated to our database for future job opportunities.
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Pasona Singapore Pte Ltd
Joanne Yeo Min Qian
EA License No:90C4069
Registration No.: R21101135
