Senior Mechanical Engineer
3 weeks ago
About the Role:
At Boston Scientific, we're seeking a highly skilled Mechanical Engineer to join our team. As a key member of our Product Development team, you'll play a critical role in providing mechanical engineering support for the maintenance of project Design History File (DHF) deliverables in our Requirements Management (RM) tool.
Responsibilities:
- Read and interpret technical drawings, procedures, and protocols.
- Import and maintain project documentation in online RM tool throughout all phases of New Product Development (NPD) and Sustaining.
- Investigate and evaluate compliance requirements driven from organization's Quality Management System (QMS)/Work Instructions and validate the same in templates developed in RM tool.
- Collaborate with cross-functional teams to understand and implement solutions to resolve compliance gap issues in documents.
- Perform validation of patches and versions of RM tool as and when available.
Requirements:
- Mechanical Engineering degree (B.E./B.Tech) with 7+ years of experience.
- Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971.
- Strong attention to detail with good communication skills.
- Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making.
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