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Certification engineer for medical devices (m/f/d)

Plattling
CSA Group
Ingenieur
Inserat online seit: 14 August
Beschreibung

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:

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.

:

1. Independently manage certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines
2. Evaluate products against requirements of the national / international standards and precedent decisions
3. Demonstrate technical competency to review the work of others and in their respective certification programs
4. Able to accurately perform evaluation and review of complex, unique or unusual product types
5. Ability to consistently manage multiple projects concurrently while maintaining on-time and on-budget performance
6. Maintain high productivity in line with company expectations
7. Reviews test data, reports and authorizes application of Certification Marks
8. Prepares and / or signs Certification Reports and Certificates of Compliance
9. Conduct construction evaluation, ensuring the unit complies with the construction section of the standard; identifies rationale for compliance or non-compliance
10. 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
11. Mentoring team members to develop their expertise in the area of responsibility
12. Writing of test reports as well as creation, review, evaluation and approval of test results and measured values
13. Customer communication in relation to project management
14. Performing risk and hazard analyses with regard to safety aspects
15. Compliance review for Software and Usability documentation
16. 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
17. Thorough knowledge of Standards and testing procedures
18. Knowledge of CSA and UL Standards is a plus
19. Knowledge IEC Standards 60601 series
20. Good English (written and spoken); German is a plus; additional languages are welcome (CB)
21. High level of interpersonal and communication skills; customer service skill
22. Strong organizational, time and project management skills to complete job tasks independently and in a time-efficient manner
23. Ability to work without supervision, in a team-based work environment
24. Read, interpret engineering drawings
25. Computer proficiency (Microsoft Office)
26. Use of various lab equipment, instruments and tools
27. Work well under a tight schedule in a team environment
28. See the big picture and the smaller pieces that contribute to success
29. Be detail oriented with the ability to deliver complex projects on time and bring breakthrough thinking and new processes to difficult situations
30. 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
31. Demonstrated ability to work across institutional, cultural and geographic boundaries with ease, consistently delivering on complex initiatives while stripping out unnecessary process and structures
32. 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

33. Flat hierarchies in a professional and intercultural corporate environment
34. Opportunity to work from home and flexible working hours
35. Attractive tasks, exciting projects and the opportunity to contribute your own ideas
36. Fitness and health program for a relaxed balance to the daily work routine
37. Lease a Bike
38. Company pension plan and opportunities for further training
39. Permanent direct employment and a future-proof job

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