Product Safety Engineer I - Medical Devices
About The Position
CSA Group is seeking a Product Safety Engineer in its Irvine, California office to support its product certification work in the medical-device sector. The role evaluates new and emerging products, systems, and technologies against safety requirements established by CSA Group and other recognized standards development organizations. Medical-device certification involves applying safety standards to equipment used in professional healthcare facilities, hospitals, clinics, and home environments, including assessing basic safety and essential performance and considering risk management. The engineer independently manages concurrent certification projects, evaluates products against national and international standards and precedent decisions, reviews test data and construction, and prepares or signs certification reports and certificates of compliance. The position also collaborates with laboratory technicians on test work orders and reviews others’ work. The role reports directly to the Product Group Managers.
Requirements
- Bachelor’s degree in Electrical or Biomedical Engineering and at least 2 years of job-related experience, or an Associate degree/Diploma in Electrical Engineering Technology or a related technical field and at least 3 years of experience.
- Thorough knowledge of standards and testing procedures.
- Thorough knowledge of CSA certification options, programs, and services applicable to a variety of equipment.
- Ability to read, interpret, and develop engineering drawings.
- Computer proficiency, including Microsoft Office.
- Ability to use electrical laboratory equipment, instruments, and tools.
- Strong interpersonal, communication, and customer-service skills.
- Strong organizational, time-management, and project-management skills, including the ability to complete tasks independently and efficiently.
- Ability to work unsupervised and in a team-based environment.
- Detail-oriented approach and ability to deliver complex projects on time and bring new thinking and processes to difficult situations.
- Ability to work across institutional, cultural, and geographic boundaries and deliver complex initiatives.
- Personal values aligned with CSA Group and commitment to its mission, values, and culture.
Nice To Haves
- Knowledge of CSA, UL, and IEC Standards 60601 series and/or 61010 series.
Responsibilities
- Independently manage concurrent certification projects, ensuring compliance with applicable safety requirements and completion within time and cost deadlines.
- Evaluate products against national and international standards and precedent decisions.
- Review the work of others and demonstrate technical competency within assigned certification programs.
- Evaluate complex, unique, or unusual product types.
- Maintain productivity and manage multiple projects to meet on-time and on-budget expectations.
- Review test data and reports and authorize application of Certification Marks.
- Prepare and/or sign Certification Reports and Certificates of Compliance.
- Conduct construction evaluations to determine whether units comply with the construction requirements of applicable standards and document the rationale for compliance or non-compliance.
- Collaborate with a Lab Technician to create work orders specifying required tests, test order, and number of samples.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
