Certification Engineer for Medical Devices
vor 3 Wochen
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.
- 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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Certification Engineer for Medical Devices
Vor 2 Tagen
Plattling, Bayern, Deutschland CSA Group VollzeitJob SummaryA 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. This position requires strong technical knowledge, analytical skills, and the ability to interpret standards, processes, and procedures.Key...
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Certification Engineer for Medical Devices
Vor 2 Tagen
Plattling, Bayern, Deutschland CSA Group VollzeitJob SummaryA 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. This position requires strong technical knowledge, analytical skills, and the ability to interpret standards, processes, and procedures.Key...
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Certification Engineer for Medical Devices
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitJob SummaryA 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. This position requires interpretation of standards, processes, and procedures, as well as providing technical guidance, analysis, and product...
-
Certification Engineer for Medical Devices
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitJob SummaryA 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. This position requires interpretation of standards, processes, and procedures, as well as providing technical guidance, analysis, and product...
-
Certification Engineer for Medical Devices
vor 4 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the RoleCSA Group is seeking a highly skilled Certification Engineer to join our team. As a Certification Engineer, you will play a critical role in ensuring the safety and compliance of medical devices.Key ResponsibilitiesManage certification projects concurrently, ensuring compliance with all applicable safety requirements and achieving completion...
-
Certification Engineer for Medical Devices
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the RoleCSA Group is seeking a highly skilled Certification Engineer to join our team. As a Certification Engineer, you will play a critical role in ensuring the safety and compliance of medical devices.Key ResponsibilitiesManage certification projects concurrently, ensuring compliance with all applicable safety requirements and achieving completion...
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Certification Engineer for Medical Robots
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the Role:We are seeking a highly skilled Certification Engineer for Medical Robots to join our team at CSA Group. As a key member of our team, you will be responsible for ensuring the compliance of medical robot products with applicable legal standards and regulations.Key Responsibilities:Interpretation of standards, processes, and procedures related...
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Certification Engineer for Medical Robots
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the Role:We are seeking a highly skilled Certification Engineer for Medical Robots to join our team at CSA Group. As a key member of our team, you will be responsible for ensuring the compliance of medical robot products with applicable legal standards and regulations.Key Responsibilities:Interpretation of standards, processes, and procedures related...
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Certification Engineer for Medical Robots
Vor 3 Tagen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the Role:We are seeking a highly skilled Certification Engineer for Medical Robots to join our team at CSA Group. As a key member of our team, you will be responsible for ensuring the compliance of medical robot products with applicable legal standards and regulations.Key Responsibilities:Interpretation of standards, processes, and procedures related...
-
Certification Engineer for Medical Robots
Vor 3 Tagen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the Role:We are seeking a highly skilled Certification Engineer for Medical Robots to join our team at CSA Group. As a key member of our team, you will be responsible for ensuring the compliance of medical robot products with applicable legal standards and regulations.Key Responsibilities:Interpretation of standards, processes, and procedures related...
-
Certification Engineer for Medical Devices
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitJob SummaryA 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 ResponsibilitiesManage certification projects concurrently, ensuring compliance with safety requirements and meeting time and cost...
-
Certification Engineer for Medical Devices
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitJob SummaryA 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 ResponsibilitiesManage certification projects concurrently, ensuring compliance with safety requirements and meeting time and cost...
-
Certification Engineer for Medical Robots
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout CSA GroupCSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices and robotics. With over 100 years of experience, we have developed a reputation for excellence and integrity in the industry.Job SummaryWe are seeking a highly skilled and experienced Certification...
-
Certification Engineer for Medical Robots
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout CSA GroupCSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices and robotics. With over 100 years of experience, we have developed a reputation for excellence and integrity in the industry.Job SummaryWe are seeking a highly skilled and experienced Certification...
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Certification Specialist for Medical Robots
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout CSA GroupCSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices and robotics. With over 100 years of experience, we have developed a reputation for excellence and integrity in the industry.Job SummaryWe are seeking a highly skilled and experienced Certification...
-
Certification Specialist for Medical Robots
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout CSA GroupCSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices and robotics. With over 100 years of experience, we have developed a reputation for excellence and integrity in the industry.Job SummaryWe are seeking a highly skilled and experienced Certification...
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Certification Specialist for Medical Robots
vor 2 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout CSA GroupCSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices and robotics. Our mission is to make the world a better, safer, and more sustainable place.Job SummaryWe are seeking a dedicated and experienced Certification Engineer for Medical Robots to join our...
-
Certification Specialist for Medical Robots
vor 2 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout CSA GroupCSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices and robotics. Our mission is to make the world a better, safer, and more sustainable place.Job SummaryWe are seeking a dedicated and experienced Certification Engineer for Medical Robots to join our...
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Certification Specialist for Medical Robots
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the Role:We are seeking a dedicated and experienced Certification Engineer for Medical Robots to join our team at CSA Group. As a key member of our team, you will be responsible for ensuring the compliance of medical robot products with applicable legal standards and regulations.Key Responsibilities:Interpretation of standards, processes, and...
-
Certification Specialist for Medical Robots
vor 1 Woche
Plattling, Bayern, Deutschland CSA Group VollzeitAbout the Role:We are seeking a dedicated and experienced Certification Engineer for Medical Robots to join our team at CSA Group. As a key member of our team, you will be responsible for ensuring the compliance of medical robot products with applicable legal standards and regulations.Key Responsibilities:Interpretation of standards, processes, and...