Design Assurance CAPA Manager - Cardiac Rhythm Management and Diagnostics (CRMDx)

Boston Scientific • Arden Hills, MN

15h • Hybrid

About The Position

This Manager of the Arden Hills based Cardiac Rhythm Management and Diagnostics (CRMDx) Field CAPA team will lead a team of 4-5 direct individuals and a number of cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantables, Medical Electrical Equipment (MEE) & Accessories product performance within the CRMDx division. This role is a tremendous opportunity for a strong technical leader, with an innate technical curiosity, who is seeking leadership, complex problem-solving, project management experience, and making a direct impact on the lifesaving and life-enhancing technologies in CRMDx and Active Implantables. The role also provides great exposure to the intricacies of how the entire portfolio of CRMDx products function, are designed, and the many parts of the organization that support their commercial use. This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations to achieve optimal results. Will also serve as liaison between the company and the various governmental agencies worldwide.

Requirements

• Bachelor’s degree in an engineering or related discipline with 8+ years of relevant experience
• Minimum of 2 years of direct supervisory experience with a passion for leadership and team development
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• Experience in Medical Device industry

Nice To Haves

• Experience with NCEPs, CAPAs, PIRs and other investigation processes.
• Experience with Active Implantables and the CRMDx division, especially at system level
• Demonstrated technical problem-solving & data analysis capabilities
• Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)
• Strong ability to successfully multi-task and demonstrate adaptability
• Project management experience (direct or cross-functional teams)
• Demonstrated effective change leadership and results-oriented focus
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams
• Demonstrated experience managing and leading multiple technical projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.

Responsibilities

• 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 cross-functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Product Inquiry Reports (PIRs), and Corrective and Preventive Actions (CAPAs). Expected to facilitate high performing teams working towards common goals and timelines.
• Reviews, approves, and creates Quality System records for NCEPs, PIRs, and CAPAs. Would represent NCEPs, PIRs, and CAPAs in internal and external audits directly or with team.
• Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues. Represents the team at key global and divisional leadership forums.
• 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.
• Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not.
• Presents updates in formal and informal reviews with all levels of the organization including high senior leadership at Boston Scientific.
• Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs, CAPAs, and PIRs. May include consulting across other BSC divisions.
• Drive improvement in Field CAPA team directly and at large in Global Communities of Practice to foster cross-communication, best practices, and improvement to investigational processes and outcomes.
• Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Benefits

• Relocation assistance is not available for this position at this time.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager