Product Safety Engineer I - Medical Devices

CSA Group • Irvine, CA

6d • Onsite

About The Position

CSA Group is seeking a Product Safety Engineer for its Irvine, California office. The role supports CSA Group’s product certification work for medical devices and other evolving technologies. The engineer evaluates products, systems, and technologies against CSA Group and other recognized standards, with particular attention to medical equipment safety, including Basic Safety and Essential Performance. The position involves applying risk-management principles and interpreting applicable requirements throughout the safety certification process.

The engineer independently manages concurrent certification projects, evaluates product designs and test results, and prepares or signs certification reports and compliance certificates. The role also includes coordinating with laboratory technicians on required tests, test order, and sample quantities, and evaluating product construction for compliance. The position reports directly to 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, with the ability to complete tasks independently and efficiently.
• Ability to work unsupervised in a team-based environment.
• Detail-oriented, with the ability to deliver complex projects on time and develop new approaches and processes for difficult situations.
• Ability to work across institutional, cultural, and geographic boundaries and deliver complex initiatives.
• Commitment to CSA Group’s mission, values, and culture.

Nice To Haves

• Knowledge of CSA, UL, and IEC 60601 series and/or 61010 series standards.

Responsibilities

• Independently manage multiple certification projects, ensuring compliance with applicable safety requirements and meeting time and cost deadlines.
• Evaluate products against national and international standards and precedent decisions.
• Review the work of others and demonstrate technical competency in assigned certification programs.
• Accurately evaluate complex, unique, or unusual product types.
• Maintain productivity and on-time, on-budget performance across multiple projects.
• 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, determine whether units comply with applicable standards, and document the rationale for compliance or non-compliance.
• Collaborate with laboratory technicians to define required tests, their order, and the number of samples needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level