Certification Engineer for Medical Devices (m / f / d)

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.

• 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
• 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 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 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
• 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 relaxed balance to the daily work routine
• Lease a Bike
• Company pension plan and opportunities for further training
• Permanent direct employment and a future-proof job