Senior Design Assurance Manager

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview. 

Boston Scientific is currently recruiting for a Senior Design Assurance Manager to lead a team in our Heredia CR location.  This is an exciting opportunity to lead a team in sustaining of single use devices for Interventional Cardiology.
 
The Senior Design Assurance Manager will provide Design Assurance leadership for Single Use Devices for the Interventional Cardiology business and will lead a team of skilled engineers.  This Design Assurance Manager will be responsible for ensuring product quality and compliance, leading the application of Design Control and Risk Management.  This Senior Design Assurance Manager will be a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving product sustainment within Interventional Cardiology Division of Boston Scientific

Key responsibilities include:

• Leads quality team in sustaining activities to support commercial product monitoring on 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.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
• Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.    
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• 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.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

 
What we're looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree in a technical field of study 
• Minimum of 10 years of related work experience or an equivalent combination of education and work experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization 
• Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
• Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
• Medical Device or regulated industry experience

 
Preferred qualifications:

• Bachelor in an engineering discipline
• Advanced degree in technical field or business. 
• Experience leading technical teams.
• Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations. 
• Familiarity with BSC products and customer needs

Requisition ID: 593539

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!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.