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Associate Design Assurance Director at Boston Scientific Corporation Malaysia

Santa Clarita, California, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Jan, 26

Salary

0.0

Posted On

24 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Assurance, Leadership, Product Development, Medical Devices, Regulatory Compliance, Process Development, Project Management, Reliability, Complaints Handling, Capital Equipment, Software, Embedded Firmware, Active Implantable Devices

Industry

Medical Equipment Manufacturing

Description

Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Your responsibilities will include: Manages both NPD, Sustaining and VIP activities with existing DA teams. Works closely with PMO to ensure the division is properly resourced to support projects Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Bachelor's degree (Engineering) Minimum of 5 years of Design Assurance Minimum of 5 years of leadership experience Master's degree (Engineering) Minimum of 5 years of supporting product development Minimum of 10 years' experience in medical devices Solid understanding of US and OUS regulations and requirements for product development Prior experience in Process Development, PMO, Reliability, Complaints handling Experience with complex capital equipment Experience with product that include Software or embedded firmware Experience with active implantable devices

Responsibilities

Ensure compliance with regulations through a robust quality system and communication with regulatory authorities. Manage NPD, Sustaining, and VIP activities while providing guidance to staff and building strategic partnerships.