What are the responsibilities and job description for the Medical Device Safety Specialist position at Wipro?
Job Overview
The Medical Device Safety Specialist will be responsible for ensuring product safety compliance by performing safety certification test assessments and supporting development activities.
The ideal candidate will have a strong background in medical device safety compliance and experience in working with cross-functional teams.
Duties and Responsibilities:
Responsibilities
The ideal candidate will work closely with the R&D team to ensure product safety compliance, which includes:
Requirements:
* BS (preferably in EE or similar major) 4 years in medical device products safety compliance evaluations,
* Fully accredited test labs such as UL, CSA, Intertek or Element, etc.
* Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) medical electrical equipment standards and including particulars & collateral standards.
About Wipro
We are Wipro, a leading global information technology consulting and business process services company.
As a part of our commitment to quality and innovation, we aim to provide excellent customer service and deliver high-quality products that meet customer expectations.
Our values include respect for individuals, integrity, and teamwork, which enable us to achieve excellence in all aspects of our business.
The Medical Device Safety Specialist will be responsible for ensuring product safety compliance by performing safety certification test assessments and supporting development activities.
The ideal candidate will have a strong background in medical device safety compliance and experience in working with cross-functional teams.
Duties and Responsibilities:
- Perform Safety certification test assessments throughout the development lifecycle.
- Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams.
- Capable of performing safety testing and Alcon products in the Alcon safety Lab and external labs.
- Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms.
Responsibilities
The ideal candidate will work closely with the R&D team to ensure product safety compliance, which includes:
- Developing and executing safety test plans and protocols.
- Coordinating with internal and external labs to ensure timely and valuable results.
- Providing technical expertise to the R&D team on safety-related matters.
Requirements:
* BS (preferably in EE or similar major) 4 years in medical device products safety compliance evaluations,
* Fully accredited test labs such as UL, CSA, Intertek or Element, etc.
* Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) medical electrical equipment standards and including particulars & collateral standards.
About Wipro
We are Wipro, a leading global information technology consulting and business process services company.
As a part of our commitment to quality and innovation, we aim to provide excellent customer service and deliver high-quality products that meet customer expectations.
Our values include respect for individuals, integrity, and teamwork, which enable us to achieve excellence in all aspects of our business.
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