Description
Summary:This Medical Test Engineer, under the strict supervision of Program Manager, is responsible for the assessment of medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related customer and project management. You will serve as liaison between the customer and the company in order to plan and execute projects, and to support the client in questions regarding regulatory and standard requirements
Requirements:
The minimum requirements of the position of Product Specialist/Test Engineer include a Bachelor's degree in engineering or related field, or foreign degree equivalent, plus at least one year of experience in product safety testing in medical device industry. Knowledge of IEC 60601 standards is a huge plus.
Duties include:
- Conducts and documents on and off site product testing to determine compliance with applicable international standards and regulations in accordance with CB, NRTL,SCC and AIMD 90/385/EEC, MDD 93/42/EEC
- Represents the test laboratory in any quality audits
- Maintains the medical device test laboratory quality system compliance through procedures development and editing as required
- Performs constructional reviews
- Keeps abreast of present and future product safety requirements, test procedures, instrumentation, technology and company engineering service capabilities by internal training sessions, external seminars and reading of technical articles
- Coordinates and performs NRTL Factory Inspections as appropriate.
If qualified and interest, please email your updated resume in Word format along with best contact times, and I will contact you to set up a time to discuss further.
To find out more about Real please visit www.realstaffing.com