Certification Engineer for Medical Devices

vor 3 Wochen


Plattling, Bayern, Deutschland CSA Group Vollzeit
Job Summary

A Certification Engineer plays a critical role in ensuring the safety and efficacy of medical devices by providing high-quality certification services that meet the needs of clients in the most efficient and effective manner possible.

Key Responsibilities
  • Independently manage certification projects concurrently, ensuring compliance with all applicable safety requirements and achieving completion within time frames and cost deadlines.
  • Evaluate products against the requirements of national and 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 the 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.
  • 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.
Requirements
  • Bachelor or Master's Degree 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.
  • 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 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 a 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.


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