Product Safety Engineer III - Medical Devices

CSA America Testing & Certification LLC; Irvine (CA); On-site; USD 92,000 - 120,000; Full time

Job summary

CSA Group, a global standards development and product certification organization, seeks an experienced Product Safety Engineer, Medical Devices in Irvine, CA to lead safety certification for innovative medical products. Reporting to the Product Group Manager, you will apply risk management principles and test methods to ensure compliance with CSA/UL/IEC standards.

The role requires a bachelor’s degree in engineering and 6+ years of related experience; strong project management, communication,

Qualifications

• High level interpersonal and communication skills required.
• Strong organizational, time and project management skills.
• Ability to read, interpret & develop engineering drawings.

Responsibilities

• Independently manage certification projects concurrently ensuring compliance with safety requirements and deadlines.
• Evaluate products against national/international standards and precedent decisions.
• Review work of others and demonstrate technical competency in certification programs.
• Prepare and sign Certification Reports and Certificates of Compliance.
• Collaborate with Lab Technician to determine required tests and sample quantities.

Skills

Interpersonal skills

Communication

Project management

Engineering drawings

MS Office

Attention to detail

Teamwork

Education

Bachelor's Degree in Engineering

Engineering Technology degree

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

• 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.

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

Skills

• 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.

Salary

The typical hiring range for this position in California is $91,760-120,435; however, based on a variety of considerations (such as education, licenses, certifications and/or, experience,) CSA Group reserves the right to flexibility outside of the stated range.

EEO and Inclusion

CSA Group is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion.

We prohibit discrimination and harassment of any kind based on any grounds stipulated by applicable laws.

We are an organization where opportunities are based on skills and abilities, and differences are respected and valued.

Please contact us at [e-mail] if you require accommodation in the interview process.

CSA Group’s Testing, Inspection, and Certification (TIC) services help customers around the world demonstrate compliance, build trust, and bring safe, reliable products to market. CSA Group’s Testing, Inspection and Certification (TIC) organization supports market access and innovation, addressing the compliance of emerging, complex technologies through expert testing, inspection, and certification services. CSA Group provides comprehensive testing, inspection, and certification services that help global manufacturers demonstrate compliance with applicable safety, environmental, and performance requirements. We support our clients’ needs in bringing their products to market with confidence, offering deep technical expertise and industry-leading service delivery across a wide range of current and emerging technologies. Our knowledgeable and helpful assistance builds trust in products, systems, and innovations used every day around the world. 140+ International Markets Our global labs provide certification services to help you access over 140 markets worldwide. Established Credibility We are a true global leader in testing, inspection, and certification, with the CSA mark appearing on billions of qualified products worldwide. Faster, Reliable Results Our turnaround times can help get your product to market with speed and efficiency.