Summary of Position:

Key Responsibilities:

• Prepare, coordinate, document post-production risk reviews per master schedule in support of on-shore Risk Management Leads and subject matter experts; coordinate query with stakeholders and/or data analysts; analyze and summarize post-production data.
• Update Risk Management Reports (and other risk management file deliverable) when/as needed and route for approval to risk management team.
• Update traceability matrices to link requirements to objective evidence – using applicable requirement management tools.
• Support Design Control engineers and other R&D stakeholders to query internal and external databases, analyze data and summarize results and conclusions in an email and/or a report.

Key Requirements/Minimum Qualifications:

• Bachelor of Engineering with 3-5 year experience; or MS Engineering generalist with demonstrated interest in multiple engineering and scientific fields.
• Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers.
• Hands on experience of ISO 14971 (Risk Management) and ISO 13485 (or US 21 CFR 820.30) or systems engineering. Some knowledge of Product Lifecycle Management (PLM) or CAD systems.
• Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote and asynchronous environment.
• Technology savviness to automate simple tasks for process improvement and cycle time reduction (e.g., data queries, data analyses, documentation)
• Knowledge on project management.

Skills and Knowledge:

• STEAM – Applied Science, Technology, Engineering, Arts and Math
• Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485)
• Systems Engineering or Risk Management for Medical Device (ISO 14971)
• Regulations and Guidelines
• Excellent Technical/Scientific Writing in English in a regulated environment
• Superior verbal English communication skill (in a remote environment)
• Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio)

Experiences

• Cross Functional collaboration - Primary
• New Product Innovation - Secondary
• Accountability - Primary
• Influencing without Authority - Primary
• Managing Crisis – Secondary
• Functional Breadth - Secondary

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

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