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Sr Eng, Advanced Surgery
ConfidentialBengaluru / Bangalore30+ days ago
Job descriptionServe as Single Point of Contact for team and collaborate with Project stakeholders. Demonstrated experience in Design and Development of medical devices, sustaining activities and related process. Knowledge of applicable FDA, EU regulations Experienced in Design Verification and Validation and writing Test protocols / reports. Develop design control requirements and Involve in the Design reviews with cross functional team. Assist the PDO for maintaining the Design History file and related documents. Assist the PRMO for maintaining the Risk Management file and related documents. Provide support to cross functional team by Understanding the needs, addressing technical queries / requirements and regulations. Provide Support as required to sustaining engineering projects. Experienced in handling Engineering / Design Change Management process. Extensive knowledge and hands on experience in Good Documentation Practice. Perform tasks with minimal supervision. Excellent Verbal and Written skills in English. Excellent communication and presentation skill. Should be able to communicate effectively in a multi-cultural working environment. Strong Collaboration and interpersonal skills. Ability to co-ordinate with stakeholders and Leadership Team. Excellent critical thinking and problem-solving skills and application of methods and tools. Willing to take ownership and take accountability for actions. Maintain timelines for successful completion of activities. Ability to identify and proactively mitigate risks. Knowledge of applicable FDA, EU regulations and ISO standards including ISO13485, ISO 14971.
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform
other duties as assigned.
- To ensure successful initiation, planning and completion of small-medium or complex project through
monitoring, tracking, and analyzing project activities and metrics.
and ISO standards including ISO13485, ISO 14971. Demonstrated experience in preparing Design History File and Product Risk Management activities.
Qualifications
Skills Required
Risk Mitigation, Iso
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