Staff Product Safety Engineer - Medical Device in Irvine

Statut d'emploi: Permanent

Type d'heures: À temps plein

Nous avons besoin de vous pour former une équipe de calibre mondial. Les activités du Groupe CSA reposent sur l’atteinte d’un idéal : rendre le monde meilleur, plus sûr et plus durable. Cet idéal est au coeur de notre mission depuis 1919, année où nous avons élaboré notre première norme d’ingénierie sur les ponts ferroviaires. Aujourd’hui, près de 100 ans plus tard, le Groupe CSA compte plus de 3 500 normes, codes et produits connexes.

Le Groupe CSA, dont le siège social se trouve au Canada, est présent à l’échelle mondiale : il possède plus de 30 laboratoires et bureaux en Europe, en Asie et en Amérique du Nord. Il propose des services de mise à l’essai, d’inspection et de certification d’une vaste gamme de produits — des articles de maison aux technologies de pointe — pour veiller à ce qu’ils répondent à des exigences strictes en matière de sécurité, de performance et d’impact sur l’environnement. Nos employés sont fiers que leur travail ait une incidence positive sur la vie des gens. Nous avons besoin de personnes comme vous pour poursuivre notre mission en ce sens.

Résumé du travail:

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. 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.
• 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 tests 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 - 61010 and 60601. 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.