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Verification Engineer
1 week ago
Imagine your future at Conavi
Join our collaborative team in the design, manufacture, and sale of an innovative intravascular imaging system to improve cardiac care.
Conavi Medical’s Novasight Hybrid System enables simultaneous imaging of a patient’s coronary arteries using both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT) technologies.
If you would like to be a part of a growing and talented team that is making a difference in healthcare, we are currently looking for a Verification Engineer (System) to develop, execute, and document the verification of Conavi's system design ensuring that the device will successfully meet requirements.
In this position, you will:
- Collaborate across functions (e.g. R&D engineering and Quality) to understand and input on system design requirements
- Document the Design Verification (DV) plan to ensure traceability to all requirements including risk items, hazards, and Failure Modes and Effects Analysis (FMEA)
- Develop system verification test protocols, plans, and cases in consultation with R&D engineering ensuring alignment with schedules and utilizing a risk-based approach
- Co-ordinate design verification configurations under test while managing and/or qualifying required equipment and fixtures
- Execute and/or co-ordinate system verification activities including testing
- Document internal or third-party testing results
- Analyse internally produced and/or third-party test results for the purposes of identifying root cause of failures and/or opportunities for design improvements where applicable
- Report test results and analysis to R&D team including as part of design review meetings
- Support the transfer of product to manufacturing
- Align with Quality and Regulatory functions to ensure verification and validation activities are compliant with quality procedures, standards, and guidelines (e.g. sample sizes, evaluation types, usability inputs)
- Contribute to reviews and improvements in the verification and validation process
- Participate in, and adhere to, health and safety initiatives and requirements
You possess the following qualifications:
- Post-secondary education ideally in engineering preferably in areas such as mechanical, electrical, mechatronics, or biomedical
- Experience in system verification and validation ideally in the medical device industry
- Proficient in design testing to functional requirements, system integration testing to product requirements, reliability testing, usability testing, as well as regression analysis/testing for design changes
- Awareness and understanding of quality standards such as ISO ideally 13485
- Knowledge and skills in statistical process measurement and data analysis
- Experience with Design of Experiment (DOE)
- Proficient in Microsoft Office applications such as Word, Excel, Outlook, Project, and Access
- Competencies include teamwork, attention to detail, analytical, time management, as well as clear and concise verbal and written communication skills
Conavi Medical values diversity and encourages applications from all qualified candidates including women, visible minorities, indigenous people, and persons with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Please submit a cover letter and resume directly to Conavi Medical through the Careers section of our website at www.conavi.com.
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