Senior Design Assurance Manager

Senior Design Assurance Manager

This is an exciting opportunity for a Senior Design Assurance Manager to join a cross-functional leadership team on the new Renal Denervation business within BSC's Cardiology division. This position will support the significant new Renal Denervation acquisition integration and product development program with high visibility which will provide the right candidate with excellent growth and development potential.

The Senior Design Assurance Manager will provide DA leadership for Renal Denervation Medical Electrical Equipment (Capital Equipment and Software) and lead a team of skilled Engineers. They will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management. They will be a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving acquisition integration, new product development, commercialization and product sustainment for Renal Denervation.

At Boston Scientific, we value collaboration and synergy. This role requires employees to be in our Arbor Lakes, MN office four days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities include:

• 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.

Required qualifications:

• Bachelor's degree in engineering or related field
• Minimum of 7 years of related 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 qualifications:

• Advanced degree in technical field or business
• Experience leading technical teams
• Prior R&D experience
• Regulatory compliance experience in the areas of medical devices, electrical products and analytical methodology
• Understanding of applicable electrical safety standards and configuration management
• Experience in reliability testing, software testing, cybersecurity testing