As Medical Device Product Quality Design Verification Engineer, you ensure that our products achieve the highest quality standards for functionality, performance, safety, and reliability. This involves scrutinizing product specifications, developing and executing test plans, validating prototypes, leading design verification activities, and driving product issue resolution during the qualification phase, ensuring regulatory compliance. The Engineer provides hardware design quality engineering expertise to engineering and manufacturing teams, as well as guidance to other departments, as necessary, on matters regarding compliance to U.S. and international related regulations and standards. The quality engineer is part of an engineering team which is working in a regulated environment. A strong background in electronics testing, failure analysis, and ISO 13485 regulatory compliance is desired.

SPECIFIC DUTIES AND RESPONSIBILITIES

· Review and interpret product specifications, ensuring all hardware, electrical, mechanical, and firmware components align with functional, performance, safety, and reliability requirements.

· Ensure that applicable product specific international standards are represented in product specifications.

· Conduct functional, environmental, electrical, and mechanical testing in compliance with IEC 60601 (medical devices), IEC 61010, FCC, and other electronics standards.

· Assess and validate electrical systems, PCB integrity, wireless communications, and interface responsiveness.

· Develop and execute hardware verification tests, including thermal cycling, humidity, vibration, drop, EMI/EMC, ESD, and ingress protection (IP testing).

· Oversee accelerated life testing (ALT), highly accelerated life testing (HALT), and highly accelerated stress screening (HASS) to predict product reliability and lifespan.

· Manage and oversee third-party testing and certification labs, ensuring adherence to compliance requirements.

· Contribute to the development process by assessing designs and identifying risks early.

· Identify, track, and prioritize product issues and defects discovered during design verification.

· Own the defect tracking system to log, prioritize (PRN) and categorize issues, facilitating efficient root cause analysis (RCA) and corrective/preventive actions (CAPA).

· Work with cross-functional teams (R&D, Manufacturing, and Quality) to drive fixes and improvements, ensuring design changes are verified and validated before implementation.

· Lead failure analysis (FA) investigations, collaborating with engineering teams to resolve issues before mass production.

· Support New Product Introduction (NPI) by ensuring manufacturing readiness and resolving hardware design issues before production ramp-up.

· Conduct qualification testing, and component validation to ensure consistency in material quality and reliability.

· Collaborate with contract manufacturers (CMs), original design manufacturers (ODMs), and vendors to ensure hardware and component compliance with design specifications.

· Design On Going Reliability Test (ORT) plans.

· Perform risk assessments to proactively identify and mitigate potential hardware design risks.

· Ensure product compliance with regulatory, environmental, and safety standards (RoHS, REACH, FDA 21 CFR Part 820, ISO 13485).

· Incorporate feedback on manufacturability, safety compliance and customer response into product requirements.

· Lead or assist in analysis of returned products.

· Design and execute test-to-failure programs to enhance product design and to anticipate customer worst case scenarios.

· Perform or coordinate failure analysis and field performance investigations.

· Define and implement reliability improvement projects.

· Perform mathematical modeling, Life time predictions, and complex reliability analysis techniques on designs to determine and simulate the life of the product in the field.

· Stay abreast of changes in medical device regulations and standards to ensure ongoing compliance.

SUPERVISORY RESPONSIBILITIES

· None

EDUCATION

· BS degree in electrical engineering, mechanical engineering, biomedical engineering, or a related field.

EXPERIENCE

· Minimum 8 years of experience in hardware product quality, design verification, and testing

· Minimum 5 years of design experience for medical devices.

KNOWLEDGE AND TRAINING

· Proficiency in hardware validation techniques, circuit analysis, and system-level testing.

· Experience with oscilloscopes, power analyzers, spectrum analyzers, thermal imaging, and vibration test equipment.

· Strong knowledge of electromagnetic compatibility (EMC), electrostatic discharge (ESD), RF/wireless performance testing, and battery validation.

· Understanding of firmware interactions with hardware and ability to work with embedded systems teams.

· Experience with test automation and scripting (Python, LabVIEW, MATLAB, or similar).

· Familiarity with ISO 13485, IEC 60601, FDA 21 CFR Part 820, FCC requirements.

· Strong problem-solving, analytical, and critical thinking abilities.

· Ability to prioritize and manage multiple projects efficiently.

· Effective communication and collaboration skills to work with cross-functional teams.

· Attention to detail and a data-driven approach to testing and validation.

· Ability to communicate clearly and concisely, both orally and in writing, with the ability to present complex information clearly to executive leadership.

· Comfortable with domestic and international travel to suppliers, manufacturers, and product development sites.

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