Job Summary:
We are seeking a highly skilled Hardware Test Engineer to join our Specialty Monitoring team. In this role, you will be responsible for testing medical devices to ensure they meet our high-quality standards and regulatory requirements.
Essential Duties and Responsibilities:
• Develop and execute test plans, test cases, and test procedures for medical devices
• Conduct rigorous testing to ensure the functionality, reliability, and safety of medical devices
• Collaborate with cross-functional teams to understand user needs, requirements, and specifications
• Work closely with hardware design engineers to identify and resolve hardware-related issues and defects
• Collaborate with suppliers to source and procure necessary test equipment
• Contribute to continuous improvement initiatives to optimize test processes
• Document test results and maintain test records
• Strong knowledge of medical device design, development, and regulatory requirements
• Circuit designing, testing, analysis, debugging, resolving field issues
• Writing System and PCBA level test cases and protocols for Verification and Validation
• Testing based on System and Compliance requirement for the medical device.
• Proficient in using CAD tools like Altium, OrCAD, or Mentor Graphics
• Knowledge in digital and analog design, embedded systems, and PCB layout
• Familiarity with regulatory requirements such as FDA, IEC, and ISO
• Strong analytical skills and problem-solving abilities
Qualifications & Personality Traits:
• Bachelor's degree in Electrical Engineering, Computer Engineering, or related field
• Minimum of 5 years of experience in hardware testing for medical devices
• Strong knowledge of medical device testing, regulatory requirements, and quality management systems
• Proficient in using test equipment such as oscilloscopes, power supplies, and multimeters
• Strong analytical skills and problem-solving abilities
• Excellent communication and interpersonal skills
• Ability to work in a fast-paced, dynamic environment
• Experience with programming microcontrollers and FPGA
• Knowledge of medical device manufacturing processes
• Familiarity with test automation and test management tools
• Agile certification or experience with agile methodologies
