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.

We, at Canadian Standards Association ("CSA Group"); a standards development and product certification organization, are seeking a Product Safety Engineer for Medical Devicesat ourIrvine 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.

MEDICAL DEVICE TESTING AND CERIFICATION AT CSA GROUP:

If working with Medical equipment and ensuring its efficacy and safety is something that ignites your passion, then this is the role for you!

CSA Group offers competitive advantages to global medical device manufacturers via its state-of-the art testing sites around the world. Due to increased longevity, global diseases, and continuing research into new treatments and procedures, companies have been developing more medical electrical equipment/system for supporting the healthcare industry. The usage of medical equipment can be found in a wide array of environments including professional healthcare facilities, hospitals, clinics, and home environment.

As medical equipment technology continuously evolves to meet the needs of global demands, and requires ongoing readiness to deal with new and emerging public health concerns, so does the development of medical safety standards used to verify its Safety and Performance. Additionally, understanding and application of Risk Management is a crucial element in the design concept of a medical equipment/system and the safety certification process. CSA Group is dedicated to ensuring that manufacturers feel confident knowing their products have been tested and certified by our diligent and expert staff.

To learn more about CSA Group, please visit:

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.

THE IDEAL CANDIDATE:

• Bachelor's degree in Biomedical Engineering or Electrical Engineering combined with medical experience.

• Preferably 3 - 5 years' experience in an engineering or compliance role for a medical manufacture or 2- 3 years' experience with IEC requirements/ ISO safety standards, preferably medical standards.

• Experience working with CSA/IEC/ISO 60601/80601 series of medical standards is ideal.

• Strong working knowledge of:

  • Operation and design of patient multifunction monitoring, sub-assemblies, equipment and systems

  • Quality Management Systems

  • Risk management medical devices

  • Software life cycle

  • Usability Engineering process

• Understanding of ISO/IEC 17025 Standard for Testing and Calibration Labs an asset

• Knowledge of process improvement tools (six sigma, lean, ISO, TQM) an asset

• The ideal candidate has strong interpersonal, communication and analytical skills with an eagerness to learn and take initiative.

• The ability to work well under a tight schedule in a team environment.

• He/she is distinguished by his/her proven ability to see the big picture and the smaller pieces that contribute to success. The ideal candidate delivers excellence by evaluating processes and procedures from the ground up and is able to effectively communicate the resulting landscape.

• Able to bring new ideas, concepts and language to even "best in class" organizations, he/she has the background and experience to make his/her ideas credible and the interpersonal skills to make them realistic. Comfortable giving up space to others with good ideas, the Product Safety Engineer has an acute sense of what is attainable.

• The ideal candidate is detail oriented and delivers complex projects without anything falling between the cracks. He/she is consistent and can bring projects in on time and bring breakthrough thinking and new processes to difficult situations. Client focused, he/she understands the power of vision, purpose, discipline and timing to keep the team on track and on budget.

• The Product Safety Engineer builds on innate knowledge by taking the initiative necessary to gain an intimate understanding of customer needs and businesses, as well as a deep familiarity of the applicable standards. In this way, he/she demonstrates an ability to instill confidence in clients and peers.

• the Product Safety Engineer understands that service time delivery and quality is as much about action as it is with words, and "walks the talk" to consistently deliver on commitments. In this regard, he/she is successful in delegating difficult tasks, and able to empower others through work.

• Steady and even keeled, the Product Safety Engineer maintains the utmost respect for clients and peers, capable of understanding not only the problem but also the underlying cause. Able to see an issue from the other person's point of view, he/she effectively leads clients through decision-making and clear feedback.

• He/she enjoys receiving insight from different sources and is able to constructively build on these ideas to create innovative solutions. The Product Safety Engineer will understand that innovation can be found anywhere but is first and foremost developed through giving people the freedom to act, creating the right processes and having comfort with risk. He/she will display exceptional insight about the relationship between innovation and the emerging marketplace.

• The Product Safety Engineer will be able to work across institutional, cultural and geographic boundaries with ease, consistently delivering on complex initiatives while stripping out unnecessary process and structures.

• The Product Safety Engineer is a leader whose personal values will align with CSA Group, and who will possess a passionate commitment, and deep respect for the organization's mission, values, and culture. He/she will be highly motivated and personally committed to making a significant difference to CSA Group.