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Validation Engineer II


OSI Systems


Location

Secunderabad | India


Job description

- Participate in design reviews and provide clinical input and design recommendations
- Create plans, protocols, reports, that are in compliance with standards, regulatory requirements, and Spacelabs New Product Development process to document activities and release new products to market.
- Plan and execute design validation activities.
- Participate in product risk identification, analysis, and mitigation.
- Provide content for and review of instructions for use.
- Provide related clinical education to RD and product management personnel.
- Stay current on industry practices.
- Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company's Code of Ethics and Conduct
- It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

- Licensed clinician such as Registered Nurse.
- Bachelor's degree in related field required. Masters' degree a plus.
- 5+ years of experience working in a clinical environment and/or other relevant experience. 3+ years of that must be clinical experience in a critical care area such as ICU – with experience in the use of patient monitors and other patient care devices, and with ECG interpretation.
- Self-motivated and experienced being a team player.
- Experience owning significant areas of product validation and test environment, including definition and executions of design validation requirements.
- Medical device industry experience highly desired.
- Ability to manage multiple, complex priorities within demanding timeframes.
- Highly developed relationship-building skills, and strong presentation and communication skills.
- Experience working positively and productively in a team environment.
- Proficient with Microsoft Office PC and comfortable learning/using other PC based tools.


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