System Engineer

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