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Boston Scientific · 1 month ago

Senior Design Assurance Manager - Interventional Cardiology and Vascular Therapy

Maple Grove, MN

Full-time

Onsite

Mid, Senior Level

$122K/yr - $232K/yr

7+ years exp

Boston Scientific is a global leader in medical science, and they are seeking a Senior Design Assurance Manager to lead a team in the Interventional Cardiology and Vascular Therapy division. This role involves ensuring product quality and compliance through Design Control and Risk Management, while collaborating with various teams to achieve new product development and sustainment.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Design ControlRisk ManagementMedical Device ExperienceRegulatory ComplianceTeam LeadershipBudget ManagementCoachingDevelopmentProduct Quality AssuranceGlobal Environment ExperienceCross-functional Collaboration

Required

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

Preferred

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)