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Certification Engineer for Medical Devices

vor 2 Monaten


Plattling, Bayern, Deutschland CSA Group Vollzeit
Job Summary

A Certification Engineer plays a crucial role in ensuring the safety and quality of medical devices by providing high-quality certification services that meet clients' needs efficiently and effectively.

Key Responsibilities
  • Manage certification projects concurrently, ensuring compliance with safety requirements and meeting time and cost deadlines.
  • Evaluate products against national and international standards, making informed decisions based on precedent.
  • Demonstrate technical expertise in reviewing the work of others and contributing to certification programs.
  • Accurately perform evaluations and reviews of complex, unique, or unusual product types.
  • Consistently manage multiple projects while maintaining on-time and on-budget performance.
  • Maintain high productivity in line with company expectations.
  • Review test data, reports, and authorize the application of Certification Marks.
  • Prepare and sign Certification Reports and Certificates of Compliance.
  • Conduct construction evaluations, ensuring compliance with the construction section of the standard.
  • Collaborate with Lab Technicians to create work orders and determine test requirements.
  • Mentor team members to develop their expertise in the area of responsibility.
  • Write test reports and create, review, evaluate, and approve test results and measured values.
  • Communicate with customers regarding project management.
  • Perform risk and hazard analyses related to safety aspects.
  • Conduct compliance reviews for Software and Usability documentation.
Requirements
  • Bachelor's or Master's Degree in Biomedical Engineering or Electrical Engineering, or state-certified Technician or Master Craftsman in Electrical Engineering with 4+ years of experience.
  • Thorough knowledge of standards and testing procedures.
  • Familiarity with CSA and UL Standards is a plus.
  • Knowledge of IEC Standards 60601 series.
  • Excellent English language skills (written and spoken); German is a plus; additional languages are welcome.
  • High level of interpersonal and communication skills, with strong customer service skills.
  • Strong organizational, time, and project management skills to complete job tasks independently and efficiently.
  • Ability to work without supervision in a team-based environment.
  • Proficiency in Microsoft Office and use of various lab equipment, instruments, and tools.
  • Ability to work well under tight schedules in a team environment.
  • Capacity to see the big picture and smaller pieces contributing to success.
  • Attention to detail with the ability to deliver complex projects on time and bring innovative thinking to challenging situations.
  • Ability to build on innate knowledge by taking the initiative to gain an intimate understanding of customer needs and businesses, as well as a deep familiarity of applicable standards.
  • Capacity to work across institutional, cultural, and geographic boundaries with ease, consistently delivering on complex initiatives while streamlining processes and structures.
What We Offer
  • Flat hierarchies in a professional and intercultural corporate environment.
  • Opportunity to work from home and flexible working hours.
  • Attractive tasks, exciting projects, and the opportunity to contribute your own ideas.
  • Fitness and health program for a balanced work routine.
  • Lease a Bike.
  • Company pension plan and opportunities for further training.
  • Permanent direct employment and a future-proof job.