
System Engineer| Medical Devices|
4 weeks ago
Job Description
POSITION TITLE: Engineer II, Systems
DEPARTMENT: Systems
REQUIRED EDUCATION: Bachelor's degree in any engineering stream
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
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