Principal Design Assurance Engineer - Field CAPA; CRMDx

Principal Design Assurance Engineer

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.

This Principal Design Assurance Engineer on the Field CAPA team will lead cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantable & Accessories product performance within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role is a tremendous opportunity for a strong technical individual, with an innate technical curiosity, who is seeking leadership, complex problem-solving, and project management experience.

The role also provides great exposure to the intricacies of how 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. May serve as liaison between the company and the various governmental agencies worldwide.

This hybrid role is based in Arden Hills, MN and requires being on-site at least three days per week.

Your responsibilities will include:

• Leading 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.
• Leading 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.
• Creating, maintaining, and enhancing 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.
• Creating and maintaining detailed investigation documentation following Good Documentation Practice guidelines.
• Creating, reviewing, and approving Quality System records for NCEPs, PIRs, and CAPAs. May represent NCEPs, PIRs, and CAPAs in internal and external audits.
• Presenting updates in formal and informal reviews with all levels of the organization including high senior leadership at Boston Scientific.
• Mentoring and guiding 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.
• Participating on behalf of the Field CAPA or Design Assurance team at large in Global Communities of Practice to foster cross-communication, best practices, and improvement to investigational processes and outcomes.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitoring and ensuring compliance with company policies and procedures.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we're looking for in you:

Required Qualifications:

• Bachelors degree in an engineering or related discipline with 8+ years of relevant experience or MS with 6+ years of experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO
  13485 Quality Standards.
• Experience in Medical Device industry

Preferred Qualifications:

• Experience with NCEPs, CAPAs, PIRs and other investigation processes.
• Experience with Active Implantable technologies and the CRMDx division
• 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 projects covering diverse engineering (i.e. Software,…