Careers

Job Brief

Candela is recognized globally for its innovating energy-based technologies that change lives and our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes.

We aspire to provide the highest levels of clinical, technical and customer support, and continue to build on the longstanding partnerships of trust we’ve established with physicians, their practices and the patients they treat.

Every role is important at Candela:       

Candela seeks a V&V Engineer your principal task will be to verify and validate multi-disciplinary complex energy based (Laser / RF / HIFU) medical aesthetic devices. This position reports to Global Director V&V Engineering and is based in Wayland, MA

• 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.

• Provide hands-on engineering support for development, integration, and verification of laser systems

• Ability to develop and execute V&V test plans, protocols, reports and test procedures to meet product 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.

• Support in preparation for medical compliance tests

• Provide input into completion of product traceability analysis from marketing and product requirements through product risk mappings in relation to verification specifications

• Uses Defect Tracking System, report and/or resolve product issues.

Background required for this role:

• Degree in Electrical / Software Engineering or similar related field.

• Ability to create robust documentation and having a strong attention to detail

• 5+ years of experience in Verification and Validation 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 62304, IEC 60601

• 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 most of the job functions.  Special projects and other tasks may be required by management.