Certification Engineer for Medical Devices in Plattling bei CSA Group
Certification Engineer for Medical Devices (m/f/d) in Plattling bei CSA Group
Regular
Full time
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 ideal 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.
A Certification Engineer provides high quality certification services which meets the clients’ needs in the most efficient and effective manner possible, while ensuring safe products are available in the public marketplace. This activity requires interpretation of standards, processes and procedures as well as providing technical guidance; analysis; product testing information; compliance and maintenance recommendations; technical reviews and independent checks. Seeks career related training and builds experience towards improving competencies needed to safeguard the integrity of CSA’s global certification programs.
These are your tasks:
- 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 and in their respective certification programs
- Able to accurately perform evaluation and review of complex, unique or unusual product types
- Ability to consistently manage multiple projects concurrently while maintaining on-time and on-budget performance
- 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
- Mentoring team members to develop their expertise in the area of responsibility
- Writing of test reports as well as creation, review, evaluation and approval of test results and measured values
- Customer communication in relation to project management
- Performing risk and hazard analyses with regard to safety aspects
- Compliance review for Software and Usability documentation
What we expect:
- Bachelor or Master’s Degree (CB) in biomedical Engineering or in electrical Engineering, alternatively state-certified Technician or Master Craftsman in electrical Engineering with 4 or more years’ experience
- Thorough knowledge of Standards and testing procedures
- Knowledge of CSA and UL Standards is a plus
- Knowledge IEC Standards 60601 series
- Good English (written and spoken); German is a plus; additional languages are welcome (CB)
- High level of interpersonal and communication skills; customer service skill
- Strong organizational, time and project management skills to complete job tasks independently and in a time-efficient manner
- Ability to work without supervision, in a team-based work environment
- Read, interpret 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 understand