Product Safety Engineer I - Medical Devices

CSA America Testing & Certification; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

CSA Group in Irvine, CA is seeking an experienced Product Safety Engineer, Medical Devices to lead safety certifications for innovative medical equipment. This role reports to the Product Group Managers and offers growth potential within a global standards organization.

You will review products against CSA, UL and IEC standards, manage certification projects, and coordinate with lab staff to plan tests and document results.

Qualifications

• Bachelor's Degree in Electrical or Biomedical Engineering with 2+ years of related experience.
• Knowledge of CSA, UL and IEC 60601 series is an asset.
• Thorough knowledge of standards and testing procedures.
• Experience in medical device certification is preferred.

Responsibilities

• Independently manage certification projects for medical devices.
• Evaluate products against national/international standards and precedent decisions.
• Review work of others and demonstrate technical competency in certification programs.
• Prepare Certification Reports and Certificates of Compliance.
• Collaborate with Lab Technicians to plan tests and determine sample quantities.

Skills

Engineering drawings interpretation

Interpersonal & communication skills

Project management

Independent / self-motivated

Team collaboration

Detail oriented

Education

BSc/BEng Electrical or Biomedical Engineering

Tools

Microsoft Office

Electrical lab equipment & instrumentation

Job description

Employment Status: Regular

Time Type: Full time

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.

Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.

Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.

Job Summary

Canadian Standards Association (\"CSA Group\"), a standards development and product certification organization, is seeking an experienced Product Safety Engineer, Medical Devices in its Irvine, CA office to further position CSA Group as the leading and pre-eminent choice for certification across all sectors. Based throughout North America and reporting directly to the Product Group Managers (PGM's), this is a dynamic opportunity with growth potential for a keen, systematic and process oriented individual who is able to see the big picture and be attentive to detail.

CSA Group offers competitive advantages to global medical device manufacturers. Due to increased longevity, global diseases, and continuing research into new treatments and procedures, companies have been developing more electronic equipment for supporting the medical industry. The usage of medical equipment can be found in a wide array of environments including professional healthcare facilities, hospitals, clinics, and home environment. As medical equipment technology continuously evolves so does the development of medical safety standards used to verify its Basic Safety and safety clinical functions, also known as Essential Performance. The understanding and application of Risk Management becomes a crucial element in the design concept of a medical equipment and the safety certification process.

The Product Safety Engineer will be responsible for the safety certification of new and leading edge products, systems and technologies based on the standards established by CSA Group and other recognized Standards Development Organizations.

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.

Education and Experience

• Bachelor's Degree in Electrical or Biomedical Engineering with 2 or more years of job related experience; or Associate Degree / Diploma in Electrical Engineering Technology or related technical field with 3 or more years' experience.


• Thorough knowledge of Standards and testing procedures


• Knowledge of CSA, UL and IEC Standards 60601 series &/or 61010 series is an asset


• Thorough knowledge of CSA certification options, programs and services applicable to a variety of equipment

Skills

• Read, interpret and develop engineering drawings.


• Computer proficiency (Microsoft Office).


• Use of various electrical laboratory equipment, instruments and tools.


• 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.


• Be detail oriented with the ability to deliver complex projects on time and bring breakthrough thinking and new processes to difficult situations.


• Demonstrated ability to work across institutional, cultural and geographic boundaries with ease, consistently delivering on complex initiatives while stripping out unnecessary process and struc

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