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Advancing possibilities for a brighter tomorrow Boston Scientific is seeking a highly motivated, experienced Design Assurance Engineer III on a permanent basis to join our team.
Job Purpose: We have an excellent opportunity for a Design Assurance Engineer to join our team in Boston Scientific in a permanent role.
As part of the Design Assurance team, a key role will be to demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system.
The team member will support the application of Design Controls in projects focusing on quality, compliance, material continuity, and Value Improvement Projects (VIPs), ensuring that all design changes are compliant to associated regulations and procedures.
In addition, the team member will support Post Market Surveillance activities such as monitoring product performance in the field and monthly signals, completing periodic safety update reports and improving the monitoring and trending processes.
The Design Assurance team supports multiple products in the Peripheral Intervention division.
Key Responsibilities: Effective understanding of requirements and procedures that govern medical device Design Control.
Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
Provide design quality support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
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