Design Assurance Director

Additional Location(s):  N/A

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:

The Design Assurance Director is a unique opportunity for a strong leader to work on a high-performing, cross-functional product development team to design and maintain world-class Electrophysiology Systems. The Design Assurance Director will serve as the Site Head of Quality (SHOQ) in our Waltham MA and Montreal design sites and will have primary Quality Assurance leadership/oversight for the rapidly growing Pulse Field Ablation (PFA) Franchise, having a direct interaction with Montreal, Heredia and Arden Hills sites.

This is an exciting opportunity to lead a team in developing and sustaining of medical electrical equipment/systems (MEE) and developing a strong System of System Organization focus on building expertise in IEC 60601, Cybersecurity and Reliability and other related topics.   The Design Assurance Director will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management.  The Design Assurance Director will be a key partner to the Research & Development, Regulatory, Post Market Quality, Supplier Quality, Marketing and Manufacturing Engineering teams in achieving new product development, commercialization, and product sustainment.

Your key responsibilities will include:

• Recruit, coach and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Lead a team of employees in the achievement of organizational goals.  Coach, direct, develop and motivate a high performing team.
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.
• Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO, etc.).
• Lead quality team on product/system development projects of major magnitude and scope.  Key Quality voice of influence on projects.
• Own and drive 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.
• Own and drive commercial product monitoring and all related product sustainment activities.
• Develop and implement quality strategies; seeks innovative approaches to attaining quality goals.
• Directly interface with internal and external audit activities.

Required Qualifications:

• Minimum of a Bachelors degree
• Minimum of 10 years of related experience
• Minimum of 5 years of direct or indirect management experience
• Regulatory compliance experience in the areas of medical devices

Preferred Qualifications:

• Advanced degree in technical fields
• Experience leading technical teams
• Prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience

Requisition ID: 583960

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.