Senior Design Assurance Manager - Reliability and Field CAPA - CRMDx

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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 Reliability and Field CAPA teams at the Arden Hills, MN location in the Cardiac Rhythm Management & Diagnostics (CRMDx) division.  This is an exciting and rewarding opportunity to lead this 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 lead this Reliability and Field CAPA team, who are 1) driving reliability understanding of products during development and commercialization through use environment characterization and product performance characterization and 2) leading cross functional teams to determine actionable root cause and implement effective solutions for issues impacting commercial 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.
• Lead team of Reliability Engineers.  The Reliability Engineers lead or support engineering evaluations and analyses for products in development and commercialized products in areas including, but not limited to 1) use environment characterization, 2) failure modes and mechanisms identification, 3) simulation and analyses creation, 4) test method and requirements development, 5) design guideline development, and/or 6) knowledge capture.  The Reliability Engineers maintain a lab with sophisticated test systems, while also evaluating/procuring/developing new cutting-edge technologies, to facilitate their own and their cross-functional partners’ evaluations. 
• Lead team of Field CAPA Engineers.  The Field CAPA Engineers lead cross-functional teams through the Corrective and Preventive Action (CAPA) process to determine actionable root cause and implement effective solutions for issues impacting commercial product performance, where suspected/confirmed root cause is product design.  This includes recruiting and leading cross-functional teams, leading cross-functional team meetings, driving efficient and effective problem solving (includes root cause identification, solution development/recommendation, solution implementation strategy development/support, and solution effectiveness verification), and presenting updates in formal and informal reviews with all levels of the organization.
• 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 team 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 in engineering or science
• 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:

• Advanced degree in engineering, science, or business
• Experience leading technical teams