Product Safety Engineer - Medical Devices

at  CSA Group

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It’s been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.
Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.
Our employees take pride in making a difference in people’s lives through the work that we do. We’re looking for people like you to help make it happen.
Job Summary:
We, at Canadian Standards Association (“CSA Group”); a standards development and product certification organization, are seeking a Product Safety Engineer for Medical Devices at our Irvine office to further position CSA Group as the leading and pre-eminent choice for medical devices certification. This is a dynamic opportunity with growth potential for a keen, systematic and process oriented individual who is able to see the big picture and be attentive to detail.
Possessing exceptional people and communication skills, the Product Safety Engineer brings an innovative customer solutions mindset, adaptability and a ‘get it done’ approach to problem solving with external customers, as well as cross functionally with internal players at all organizational levels. With strong project management and process control experience, the Product Safety Engineer has a demonstrated track record and grasp of the discipline and balance required in product certification along with the high level of customer care required in a risk management and/or certification environment.

KEY ACCOUNTABILITIES:

You will be responsible for the safety certification of new and leading-edge products, systems and technologies based on the standards established by CSA Group and other recognized Standards Development Organizations. This particular role will cover the testing and certification of a variety of medical products which include: Transcutaneous Partial Pressure, Automated Non-Invasive Blood Pressure - sphygmomanometers (NIBP), Invasive Blood Pressure (IBP), Respiratory Gas Modules (RGM), Electrocardiographs (ECG), Electroencephalographs (EEG), Patient temperature, Pulse Oximeters (SPO2) and others.

Here are some of the specific tasks the role is required to perform:

• Independently manage certification projects concurrently ensuring compliance with the applicable safety requirements achieving completion within time frames and cost deadlines. Evaluate products against requirements of the national / international medical standards and precedent decisions.
• Determine scope and plan, including identification of equipment and resources needed to complete the testing.
• Assist to the tests or perform tests per safety test protocols and associated standards
• Compile, review, and approve test results and record data in test protocols, and test reports
• Demonstrate technical competency to review the work of others.
• Demonstrate technical competency in their respective certification programs.
• Able to accurately perform evaluation and review of complex, unique or unusual product types.
• Demonstrates the ability to consistently manage multiple medical projects concurrently while maintaining proposed schedule.
• Able to maintain high productivity in line with company expectations.
• Reviews test data, reports and authorizes application of Certification Marks. Prepares and / or signs Certification Reports and Certificates of Compliance.
• Conduct construction evaluation, ensuring the unit complies with the applicable standards; identifies decision based on rationales for compliance or non-compliance.
• Collaborate with Lab Technician to create a work order which test are required and; the sequence of testing, test setup and test procedure.
• Client interactions/communications; request of information, communication of non-conformances, managing project timelines and setting expectations.
• Working well within a team environment; collaboration with team members and potential mentorship of colleagues.

• Independently manage certification projects concurrently ensuring compliance with the applicable safety requirements achieving completion within time frames and cost deadlines. Evaluate products against requirements of the national / international medical standards and precedent decisions.
• Determine scope and plan, including identification of equipment and resources needed to complete the testing.
• Assist to the tests or perform tests per safety test protocols and associated standards
• Compile, review, and approve test results and record data in test protocols, and test reports
• Demonstrate technical competency to review the work of others.
• Demonstrate technical competency in their respective certification programs.
• Able to accurately perform evaluation and review of complex, unique or unusual product types.
• Demonstrates the ability to consistently manage multiple medical projects concurrently while maintaining proposed schedule.
• Able to maintain high productivity in line with company expectations.
• Reviews test data, reports and authorizes application of Certification Marks. Prepares and / or signs Certification Reports and Certificates of Compliance.
• Conduct construction evaluation, ensuring the unit complies with the applicable standards; identifies decision based on rationales for compliance or non-compliance.
• Collaborate with Lab Technician to create a work order which test are required and; the sequence of testing, test setup and test procedure.
• Client interactions/communications; request of information, communication of non-conformances, managing project timelines and setting expectations.
• Working well within a team environment; collaboration with team members and potential mentorship of colleagues