Quality Verification Engineer
Openwater
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.