Senior Design Assurance Manager - Cardiac Rhythm Management & Diagnostics

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 a Senior Design Assurance Manager to lead our team at the Arden Hills, MN location in the Cardiac Rhythm Management & Diagnostics (CRMDx) division.  This is an exciting and rewarding opportunity to lead the Design Assurance team, in collaboration with our cross-functional partners, developing and sustaining lifesaving and life-enhancing technologies for patients with rhythm disorders and heart failure from diagnosis to treatment, including Cardiac Implantable Electronic Device (CIED) systems, Medical Electrical Equipment (MEE), Remote Patient Monitoring (RPM) systems, and Single Use Devices (SUDs).  The Senior Design Assurance Manager will drive the team to ensure product quality and conformance to global standards and regulations through the application of Design Control and Risk Management, while leading with a keen focus on patient safety and reliable product performance, in close partnership with Research & Development, Regulatory, Medical, Marketing, Manufacturing Engineering, and Project Management.

Your responsibilities will include:

• Leads a team of employees in the achievement of organizational goals, project goals, and career goals.  Recruits, hires, supports, and develops a high performing team.
• Leads Design Assurance team through product development and sustainment projects of major magnitude and scope, including the completion of functional deliverables and serving as the voice of Quality, supporting technical excellence across the project.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Develops and implements quality strategies; seeks innovative approaches to achieving quality goals.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Maintains and enhances cross-functional partner relationships.
• Develops department budget and monitors spending.  Determines appropriate staff levels and schedules.  Works with cross-functional partners to understand priorities and plans resource allocation accordingly.
• Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).  May serve as liaison between the company and the various governmental agencies worldwide.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

What we’re looking for:
Required qualifications

• Minimum of a Bachelor's degree 
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Minimum of 5 years of direct or indirect supervisory experience with a passion for leadership and team development
• Medical Device or regulated industry experience

Preferred qualifications

• Bachelor’s degree in engineering
• Advanced degree in science, engineering, or business
• Experience leading technical teams
• R&D experience
• Design Controls and Risk Management experience
• FDA/ISO Medical Device Regulations experience
   

 

 

 

Requisition ID: 601738 

Minimum Salary: $ 122100 

Maximum Salary: $ 232000 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift different