- 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%).
- 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.
- Bachelors 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.
- Five to eight years' progressive work experience in a relevant technical field.
- Bachelors 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
Pay Range:
- $45-50/Hr
- EMC
- Electrical
- Biomedical
- Physics
- Product Safety testing
- PCB CAD
- ORCAD
- CAPA
- UL/CSA/IEC 61010
- UL/CSA/IEC 60950/62368-1
- IEC/EN 61326-1
- IEC/EN 61326-2-6
- lectro-Mechanical
- Medical device
- R&D
- Engineer
- Engineering
- FDA
- GMP
- electromechanical
Job ID: 483446311
Originally Posted on: 6/30/2025
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