Senior Design Assurance Manager - Electronic Medical Equipment (EME)

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 Electronic Medical Equipment (EME) Interventional Oncology (IO) Products.
 
The Senior Design Assurance Manager will provide Design Assurance leadership for Single Use Device, New Product Development and Integration for the Peripheral Intervention (PI) Interventional Oncology (IO) 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 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.
• 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:

• Bachelor's degree 
• Minimum of 8 years of related work experience or an equivalent combination of education and work experience
• Minimum of 4 years leadership experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization  
• Software and Electronic Medical Equipment (EME) experience 
• 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 of Science 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: 

Minimum Salary: $ 122100 

Maximum Salary: $ 232000 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered b