Product Safety Engineer III - Medical Devices (Irvine)

Overview

Certify medical device safety per CSA, UL, IEC standards

Key Responsibilities

• work order
• project management
• engineering drawings
• lab equipment
• construction evaluation
• certification reports

Tasks

-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. -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. -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. -Read, interpret and develop engineering drawings. -Reviews test data, reports and authorizes application of Certification Marks. Prepares and / or signs Certification Reports and Certificates of Compliance. -Use of various lab equipment, instruments and tools. -Conduct construction evaluation, ensuring the unit complies with the construction section of the standard; identifies rationale for compliance or non-compliance. -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.

Requirements

• project management
• microsoft office
• bachelor's engineering
• csa standards
• technical certification
• communication

What You Bring

-Possess strong organizational, time and project management skills to complete job tasks independently and in a time-efficient manner. -Thorough knowledge of Standards and testing procedures -Computer proficiency (Microsoft Office) -Demonstrates the ability to consistently manage multiple projects concurrently while maintaining on-time and on-budget performance. -Ability to work unsupervised, in a team-based work environment. -Be detail oriented with the ability to deliver complex projects on time and bring breakthrough thinking and new processes to difficult situations. -Able to accurately perform evaluation and review of complex, unique or unusual product types. -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. -Work well under a tight schedule in a team environment. -High level of interpersonal and communication skills; customer service skills. -Demonstrate technical competency in their respective certification programs. -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 -Demonstrated ability to work across institutional, cultural and geographic boundaries with ease, consistently delivering on complex initiatives while stripping out unnecessary process and structures. -Able to maintain high productivity in line with company expectations.

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About Csa Group

-Through its non-profit standards arm and commercial testing, inspection, and certification subsidiaries, it generates revenue while advancing technical standards. -Typical projects include certifying household products, industrial equipment, energy systems, and medical devices to rigorous safety and performance standards. -Sector specialisms span quality codes & standards, testing & certification, energy efficiency, cybersecurity, industrial and hazardous locations, medical and laboratory equipment, and building products. -Notably accredited by the Standards Council of Canada, its iconic registered mark signals independent validation of safety and compliance. -An unusual fact: its testing arm funds its standards mission, enabling a self-sustaining model blending commercial and public good.

Sector Specialisms