|The Company is a pioneer in medical robotics and world leader in image-directed, robotic products for orthopedic applications. The Company’s product allows surgeons to pre-operatively plan their surgery in a 3-D virtual space and then execute the surgery in the operating room, exactly as planned.
The compliance engineer will be responsible for evaluating and testing medical electrical devices to determine compliance with applicable standards, including the IEC 60601 series. He/she will supervise the testing and conduct the assessment of equipment in accordance with recognized standards including IEC 60601. He/she will work with other testing laboratory staff to meet the commercial and quality objectives of the business. The engineer will apply technical knowledge of the standards during planning of tests and assessment of equipment. The engineer will manage projects with engineering to ensure systems are compliant with the requirements of these agencies/conformity assessment schemes: ANVISA, CCC, CE, FDA, FCC, KFDA, and RoHS. The engineer will review reports and test records of other testing laboratory staff and undertake other reasonable tasks as allocated.
This position may require less than 25% travel.
?Independently conduct on and off site evaluation of products to determine compliance with applicable standards including IEC 60601-1.
?Perform testing of products in accordance with standards including rating, leakage current, dielectric, temperature, pressure, stability, mechanical hazard, flammability, etc.
?Identify critical components from NRTL files
?Create agency reports with relevant information
?Create IEC Test Report Forms (TRF) and updates as necessary
?Schedule and manage electrical safety and Electromagnetic Compatibility (EMC) testing
?Ensure design meets and exceeds product specifications, regulatory requirements, and international safety standards such as IEC 60601-1.
?Familiar with Medical Device standards (ISO 13485, ISO 14970 and 21 CFR 820
?Excellent written and verbal communication skills.
?Experienced in drafting Engineering test protocols and reports.
?Experienced with basic measurement equipment
?Experienced in hands-on engineering testing.
?Interfaces with other functional departments including quality assurance, regulatory affairs, and marketing, to ensure effective collaboration and teamwork.
?A Bachelor’s Degree in electrical engineering or related science.
?4+ years’ experience applying medical device standards and regulations
?Detailed knowledge of IEC 60601-1 and IEC 60601-1-2 Requirements
?Proven ability to produce IEC 60601 project prerequisites including insulation diagrams, labeling, RMF, PEMS, etc.
?Experience working with Independent Test Labs and Certification Bodies (e.g., UL, ETL) to qualify products to international standards
?A working knowledge of Nationally Recognized Testing Laboratories (NRTL’s)
?Experience applying standards to support worldwide market clearances such as 510(k), CE Mark, Shonin, INMETRO
?Experience working with suppliers to obtain necessary regulatory compliance documentation.
?Excellent communication and technical writing skills
?Ability to work productively and proactively with technical, multi-disciplinary product teams
?Strong organizational and work planning skills, detail oriented
?Excellent problem solving/analytical abilities
?Ability to manage multiple tasks in a time sensitive environment
?Excellent interpersonal communication and project/time management skills.
?Self-motivated with a strong work ethic.
?Experience developing test procedures and reports.
?Strong scientific/technical writing ability
|Curexo Technology Corporation|
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