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 (Positive Documentation Practice & Good
- Manufacturing practice

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

Experience: 2.00-4.00 Years

📌 System Engineer (Bengaluru)
🏢 3G HR Services
📍 Bengaluru