Position Details:
Industry: Medical Devices
Job Title: R&D Engineer (Circuit Design) - Onsite
Location: Princeton, NJ 08540
Duration: 12+ Months [+ Possibilities of extension]
Pay Range: $40-$45/hr
Description:
• 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%).
Qualifications:
• 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.
• 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.
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