Senior Design Assurance Manager

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.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Design Assurance Manager on a permanent basis to join our team here at our Galway facility. 

Job Purpose:

This is an exciting opportunity for a Senior Design Assurance Manager to join a cross-functional leadership team on the new c 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.

Key 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.

Education & Experience:

Required qualifications:

• Level 8 Honors Bachelor's degree in engineering or related field (STEM) 
• 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
• 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

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 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!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.  Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.

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