Hardware Test Engineer
4 days ago
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
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
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