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System Engineer

ConfidentialBengaluru / Bangalore

30+ days ago

Job description

SKILLS & RESPONSIBILITIES :

Minimum 2- 4 years relevant experience and / or training related

to systems engineering

Knowledge of medical device technology, applicable quality and

safety standards, and regulations (ISO 60601-x)

Demonstrated ability to deal with a fast-paced environment, high

levels of ambiguity, multiple concurrent projects, and conflicting

assignments

Demonstrated initiative, attention to detail, customer focus, and

commitment to ongoing process improvement

Experience with requirements specification and traceability

Knowledge of product life-cycle management

Experience with project management a plus

Experience with documentation of design / development activities

Understanding of medical devices and human respiration system

Experience in risk management and ISO 14971 is added advantage

Knowledge of FDA regulations and Medical Devices Directive

93 / 42 / EEC

GDP & GMP Experiences (Good Documentation Practice & Good

Manufacturing practice

Skills Required

Process Improvement, Product Life Cycle Management, Medical Devices, Gmp

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System Engineer • Bengaluru / Bangalore

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