Senior Design Assurance Manager - Interventional Cardiology and Vascular Th at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Design Controls, Risk Management, Product Performance, Compliance, Verification and Validation, Failure Investigations, Commercial Product Monitoring, Quality Strategies, Team Development, Budget Management, Cross-Functional Collaboration, Technical Guidance, Regulatory Compliance, Electrical Safety Standards, Configuration Management

Industry

Medical Equipment Manufacturing

Description

Leads quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects. Leads quality team on functional deliverables and ensures technical excellence for product or technical development. Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives. Including leading V&V activities and failure investigations. Owns and drives commercial product monitoring and all related product sustainment activities. Develops and implements quality strategies; seeks innovative approaches to attaining quality goals. Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff. Develops department budget and monitors spending. Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly. Maintains and enhances cross-functional team relationships. Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues. Lead a team of employees in the achievement of organizational goals. Coach, direct, and develop a high performing team. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Directly interfaces with internal and external audit activities. Minimum of a Bachelor's degree Minimum of 7 years of related work experience or an equivalent combination of education and work experience Minimum of 5 years of direct or indirect management experience with a passion for leadership and team development Medical Device or regulated industry experience Advanced degree in technical field or business Experience leading technical teams Regulatory compliance experience in the areas of medical devices; Understanding of applicable electrical safety standards and configuration management (e.g IEC 60601, 62304) Experience working in global environment (e.g. Costa Rica, APAC, Ireland)

Responsibilities

Leads the quality team on product/system development projects and ensures technical excellence for product development. Drives deliverables related to design controls, risk management, and compliance while fostering a high-performing team.