Senior Design Assurance Manager

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:
 
Boston Scientific is currently recruiting for a Senior Design Assurance Manager to lead a team in our Maple Grove MN location.  This is an exciting opportunity to lead a team in developing, integrating, and sustaining of single use embolic device. 
 
The Senior Design Assurance Manager will provide Design Assurance leadership for Single Use Device New Product Development and Integration for the Peripheral Interventions (PI) Interventional Oncology & Embolization business and will lead a team of skilled engineers.  This Senior 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 new product development, commercialization, and product sustainment within Peripheral Intervention Division of Boston Scientific

Your responsibilities 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.
• 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.
• Partners with Sustaining to support commercial product monitoring and all related product sustainment activities.
• 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 
• Minimum of 8 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:

• BS 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: 585343

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.