Product Safety Engineer III - Medical Devices
About The Position
CSA Group is seeking an experienced Product Safety Engineer for its Irvine, California office. The role supports CSA Group’s product certification work, evaluating medical devices and other products, systems, and technologies for compliance with safety standards established by CSA Group and other recognized standards development organizations. Medical equipment is used in professional healthcare facilities, hospitals, clinics, and home environments. The role applies safety standards concerning basic safety and essential performance, as well as risk management, as part of product design review and safety certification. The engineer independently manages multiple certification projects, evaluates products against applicable national and international requirements, reviews technical work, test data, and reports, and authorizes certification marks. The position also includes construction evaluations and collaboration with laboratory technicians on test work orders. The role reports directly to Product Group Managers.
Requirements
- Bachelor’s degree in Engineering with likely 6 or more years of job-related experience, or a degree/diploma in Engineering Technology or a related technical field with 8 or more years of experience.
- Thorough knowledge of standards and testing procedures.
- Knowledge of CSA, UL, and IEC Standards 60601 and 61010.
- Thorough knowledge of CSA certification options, programs, and services applicable to a variety of equipment.
- Strong interpersonal, communication, and customer service skills.
- Strong organizational, time-management, and project-management skills, with the ability to complete tasks independently and efficiently.
- Ability to work unsupervised in a team-based environment and under tight schedules.
- Ability to read, interpret, and develop engineering drawings.
- Computer proficiency, including Microsoft Office.
- Ability to use various laboratory equipment, instruments, and tools.
- Detail-oriented approach and ability to deliver complex projects on time.
- Ability to understand customer needs and businesses and develop familiarity with applicable standards.
- Ability to work across institutional, cultural, and geographic boundaries and deliver complex initiatives.
- Commitment to CSA Group’s mission, values, and culture.
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 in the relevant certification programs.
- Evaluate complex, unique, or unusual product types.
- Maintain multiple projects with on-time, on-budget performance and productivity aligned with company expectations.
- Review test data and reports and authorize the application of Certification Marks.
- Prepare and/or sign Certification Reports and Certificates of Compliance.
- Conduct construction evaluations to verify compliance with the construction section of applicable standards and document the rationale for compliance or non-compliance.
- Collaborate with Lab Technicians to create work orders specifying required tests, test sequence, and sample quantities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
