The Senior System Verification Engineer holds the responsibility to verify the overall system performance, feature interaction and user interfaces of multi-disciplinary complex energy based (Laser / RF / HIFU) medical aesthetic devices.
Essential Job Functions
The ideal candidate possesses the ability to work both independently and as part of a team, with strong written and verbal communication skills. The person must be organized, detail oriented. The candidate ensures quality-engineering work and collaborates with experts in various disciplines (DQA, NPI, Sustain and Regulatory groups) in the integration, test, and evaluation of laser systems.
Own and support system verification, as a core team member and leader
Provide hands-on engineering support for system integration, system protocol definition, feature integration and verification of laser systems.
Provide test support related to design margin testing, operational environmental, packaged testing and performance testing
Lead alpha and beta testing including test definition, test plan creation, test protocol definition, site support and report creation.
Ability to create and execute verification test plans, protocols, reports and test procedures to meet system and low level design requirements in accordance with internal company processes and international medical regulations.
Verification planning, assembly, test preparation, and maintenance of engineering prototype medical systems.
Troubleshooting; optic, mechanic, hardware and software; test data analysis.
Provide support to clinic and usability lead for user preference test and usability tests
Support both alpha and beta tests
Support in preparation for medical compliance tests
Provide product traceability related to PRD, SRS and HRD through the requirements management tools, ensuing that all risks are addressed with safe and effective mitigations.
Utilize Defect Tracking System, report and/or resolve product issues.
Ability to analyze field issues and create test cases to stimulate system (Fault Integration)
Degree in Biomedical/Electrical/Computer science or similar related field.
Ability to create robust documentation and having a strong attention to detail
5+ years of experience in Verification under Medical Device Regulations
Experience in an FDA regulated environment that meet internal quality requirements and regulatory standards for Class II medical devices
Familiarity with FDA 21 DFR 820.30, ISO 14791, IEC 60601, IEC62304, IEC62366, HE74, HE75
Familiarity with SW and System automated test tools – strong advantage
Strong Analytical and problem-solving skills
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.
Candela Corporation is proud to be an Equal Employment Opportunity and Affirmative Action Employer and is committed to creating a diverse and inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.