CSA Group · 8 hours ago
Staff Product Safety Engineer - Medical Device
CSA Group is a standards development and product certification organization, and they are seeking an experienced Product Safety Engineer for Medical Devices in their Irvine, CA office. The role involves managing certification projects for medical equipment, ensuring compliance with safety standards, and collaborating with technical teams to evaluate and certify products.
AssociationEducationNon ProfitTraining
Responsibilities
Independently manage certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines. Evaluate products against requirements of the national / international standards and precedent decisions
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 projects concurrently while maintaining on-time and on-budget performance
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 construction section of the standard; identifies rationale for compliance or non-compliance
Collaborate with Lab Technician to create a work order which test are required and; the order of the tests and the number of samples required
Qualification
Required
Bachelor's Degree in Engineering with likely 6 or more years of job related experience; or Degree / Diploma in Engineering Technology or related technical field with 8 or more years' experience
Thorough knowledge of Standards and testing procedures
Knowledge of CSA, UL and IEC Standards - 61010 and 60601
Thorough knowledge of CSA certification options, programs and services applicable to a variety of equipment
High level of interpersonal and communication skills; customer service skills
Possess strong organizational, time and project management skills to complete job tasks independently and in a time-efficient manner
Ability to work unsupervised, in a team-based work environment
Read, interpret and develop engineering drawings
Computer proficiency (Microsoft Office)
Use of various lab equipment, instruments and tools
Work well under a tight schedule in a team environment
See the big picture and the smaller pieces that contribute to success
Be detail oriented with the ability to deliver complex projects on time and bring breakthrough thinking and new processes to difficult situations
Build 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
Demonstrated ability to work across institutional, cultural and geographic boundaries with ease, consistently delivering on complex initiatives while stripping out unnecessary process and structures
Serve as 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
Company
CSA Group
CSA Group is a not-for-profit standards organization which develops standards in 57 areas.
H1B Sponsorship
CSA Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (6)
2022 (2)
2021 (3)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
$0.44MKey Investors
Natural Resources Canada
2025-12-16Grant· $0.44M
Leadership Team
Recent News
Government of Canada
2025-12-16
Medical Xpress - latest medical and health news stories
2025-11-03
Energy Connections Canada
2025-10-16
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