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 Client
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 Client 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
Required
• Education:
• 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.
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com
Regards
Niraj kumar
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