Collabera Inc.
- Experience in the R & D of Electro-Mechanical Medical device with understanding of full system including Feasibility, prototype development, and working with cross functional teams.
- Experience in the design of Mixed signal Analog-Digital circuit design and design analysis.
- Facilitate a systems-level approach to EMC, Wireless and Product Safety compliance for new product development and existing product by collaborating with Electrical and Mechanical engineering as needed.
- Write EMC Test Plans and Reports based on IEC/EN 61326-1, IEC/EN 61326-2-6, and other applicable external standards as needed
- Able to set up EMC and Safety test equipment and write/maintain equipment operating procedures.
- Perform and/or provide guidance on Product Safety testing as required by UL/CSA/IEC 61010 and UL/CSA/IEC 60950/62368-1.
- Perform EMC troubleshooting of test equipment and equipment under test as needed and communicate any EUT performance issues as they occur.
- Perform EMC/Safety assessments for proposed design changes and provide design recommendations to R&D engineers and management
- Perform and complete software and equipment validations to support product testing following the Quality System
- Completes professional level engineering assignments related to EMC and Product Safety.
- Leads and participates in projects involving the design, fabrication, and manufacture of complex instrument subassemblies, systems or processes.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Interact with external certifying agencies during the creation and maintenance of UL Files, CB Scheme and CE Marking Technical Files.
- Proven experience to develop test methods, Write/Execute Verification and Validation protocols and Reports, CAPA investigation.
- Travel as necessary to aid in program facilitation or for training (5%).
Expected Skills/Attributes
- A self-driven professional with the highest level of integrity in the successful completion of your work.
- Experience working with PCB CAD and Layout tools (ORCAD Capture, Mentor Graphics PADS, Pspice for Simulation)
- Strong technical background and knowledge of the EMC testing and Product Safety procedures/standards
- Advanced organizational skills and attention to detail.
- Excellent oral and written communication and documentation skills.
- Pro-active problem-solving skills.
- The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
- Must be able to collaborate with multi-disciplinary groups and functions on site.
- Effectively interface with external certification agencies.
- Familiarity with EMC/Safety test equipment and methods, and general laboratory test equipment.
- Ability to adapt and work in a FDA regulated environment.
- Knowledge of regulations, standards and Directives affecting the IVD medical device industry is a plus.
EDUCATION AND EXPERIENCE, YOU’LL BRING
- Bachelor’s degree in an engineering or related discipline, ideally in electrical engineering or equipment safety. Two years’ post-secondary education in an engineering field with an additional two years practical engineering or technician experience is acceptable. This education is required to comprehend basic engineering principles in order to apply them to instrument design and product support tasks.
Background:
- Five to eight years’ progressive work experience in a relevant technical field.
Preferred - Bachelor’s Degree in Electrical, Biomedical Engineering or Physics with a minimum of 5 to 8 years work experience in circuit design, EMC, Wireless and Product Safety testing
Electrical Engineering,EMC,Product Safety,PCB,Analog,Digital
To apply for this job please visit collabera.com.