Boston Scientific Principal Quality Systems Engineer - Configuration Management 

United States, Minnesota 

198125540

This role will offer you the opportunity to engage with a diverse group of stakeholders, from engineers to leadership, across multiple divisions. You will help establish a unified approach to configuration management that spans the entire lifecycle of capital equipment, ensuring that our processes, policies, and systems are aligned with the highest standards of quality, compliance, and operational efficiency.

Your responsibilities will include:

• Project Leadership: Serve as the Technical Lead for a strategic project focused on Capital Equipment Configuration Management, involving hardware, software, and systems configuration management, partnering with a Project Manager and cross-functional teams to drive successful outcomes.
• Configuration Management Expertise: Lead technical discussions and guide decision-making around configuration management for complex capital equipment, including hardware, software, and systems, ensuring best practices are followed throughout the lifecycle.
• Collaboration: Work alongside other project leads within the Capital Equipment QA portfolio to define a unified approach to configuration management—addressing inputs, considerations, outputs, and decisions across the equipment lifecycle.
• Documentation Development: Lead the creation and maintenance of Standard Operating Procedures (SOPs), Work Instructions, and Guidance documents to ensure consistency and compliance across configuration management activities.
• Stakeholder Management: Lead a cross-functional, cross-divisional stakeholder group, including engineers, quality professionals, and senior leadership, to ensure alignment and effective decision-making.
• Executive Communication: Present regular project updates and report-outs to Director and VP-level leadership, ensuring alignment with broader organizational goals.
• IT Systems Requirements: Partner with IT teams to define and support the design of IT system requirements to facilitate effective configuration management, ensuring technology solutions meet operational needs.
• Process Improvement: Drive continuous improvement in configuration management processes, ensuring they are scalable, efficient, and aligned with regulatory and quality standards.

Required Qualifications:

• Bachelor's degree in Engineering, Quality, or a related technical discipline.
• 8+ years of experience in quality assurance, engineering, or related fields, with strong experience in configuration management of complex medical devices or similar capital equipment.
• Expertise in configuration management principles, including lifecycle management, change control, and traceability, with an understanding of hardware, software, and systems configuration.
• Strong technical acumen to guide configuration management discussions and decisions, ensuring the highest level of quality and compliance.

Preferred Qualifications:

• Master's degree
• Experience working on cross-functional teams, collaborating with engineers, quality professionals, and senior leadership.
• Ability to effectively communicate technical concepts and project progress to executive leadership.
• Familiarity with regulatory standards (e.g., ISO, FDA) and quality management systems (e.g., QMS, CAPA).
• Proven ability to influence and drive alignment across a variety of stakeholders at different organizational levels.
• Project management experience is a plus, but the focus for this role is on providing strong technical leadership for the project’s configuration management aspects.
  

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.