Senior Design Assurance Manager - Electrophysiology

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role
Boston Scientific is recruiting for a Senior Design Assurance Manager at our Mississauga, ON location. This exciting role involves leading a team within the Access Solutions franchise, focusing on developing and sustaining single-use devices for improving workflow to gain access to the left side of the heart.  The role is hybrid with the expectation to be on-site three days a week.

The Senior Design Assurance Manager will provide leadership in design assurance and oversee a team of skilled engineers and leaders. The role is responsible for ensuring product quality and compliance by applying Design Control and Risk Management processes. This position is a key partner to the Research & Development, Medical, Regulatory, Marketing, and Manufacturing Engineering teams, contributing to new product development, commercialization, and product sustainment within the rapidly growing Electrophysiology (EP) division of Boston Scientific.

Your responsibilities will include:

• Leads quality team on product 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 in the achievement of organizational goals. 
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance
• Owns and drives commercial product monitoring and all related product sustainment activities.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.
• Driving functional excellence in Design Assurance (DA) by developing, coaching, mentoring, and leadership on product design changes, while ensuring technical excellence.
• Develops department budget and monitors spending. 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.
• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.
• Other duties as required.

 
Required qualifications:

• Bachelor's degree and 7+ years of related work experience or an equivalent combination of education and work experience
• 5+ years of direct or indirect supervisory experience with a passion for leadership and team development
• Experience with conflict resolution, negotiation, and influencing others
• Experience with design controls and risk management activities
• Medical device or regulated industry experience
• Ability to travel domestically and internationally as requested

 
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, combination products, pharmaceuticals, and analytical methodology
• Experience with single use devices in cardiology 

Learn more about our Transseptal Access Devices 

Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices  

Requisition ID: 594095

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!