Additional Location(s): US-MN-Maple Grove
About the role:
This team is seeking a Principal Quality Engineer to support the Core Technology Polymer team within Maple Grove Operations. In this role, you will develop, implement and maintain quality engineering systems, methodologies and practices that ensure compliance with Boston Scientific, customer and regulatory requirements.
As a key Quality representative, you will provide technical leadership and partner across functions to drive quality initiatives that support operational excellence, product quality and business objectives. You will play a critical role in process validation, risk management, process controls and continuous improvement efforts, ensuring products consistently meet internal and external requirements throughout the product lifecycle. Working in a collaborative environment, you will lead quality engineering projects, mentor technical team members and apply data-driven problem-solving approaches to identify, resolve and prevent quality issues while strengthening manufacturing processes and quality system effectiveness.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at Maple Grove, MN least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include:
• Lead departmental and cross-functional quality engineering initiatives that support business and operational objectives.
• Provide project leadership, coaching and technical mentorship to engineering and quality team members.
• Drive the implementation of best-in-class quality engineering practices and continuous improvement initiatives.
• Lead process validation, verification and risk management activities to ensure product and process robustness.
• Develop and implement effective process controls that support product development, qualification and ongoing manufacturing.
• Support and strengthen quality system processes, including CAPA, investigations and process monitoring activities.
• Apply structured problem-solving methodologies to identify, prioritize and resolve quality issues.
• Partner with manufacturing, process engineering, supplier quality and cross-functional teams to drive sustainable improvements.
• Analyze quality and manufacturing data to identify trends, risks and opportunities for improvement.
• Ensure compliance with applicable quality system requirements, documentation standards and regulatory expectations.
Required qualifications:
• Minimum Bachelor's degree in Engineering or a related technical discipline and 5 years' experience in quality engineering, manufacturing engineering or a related technical field.
• Proven experience supporting process validation, process verification and risk management activities, including Design and Process FMEAs.
• Demonstrated Knowledge of statistical analysis, data interpretation and quality engineering tools.
• Strong written, verbal and presentation skills with the ability to communicate effectively across organizational levels.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Working knowledge of quality systems and good documentation practices.
Preferred qualifications:
• Proven experience managing multiple projects across diverse engineering disciplines.
• Medical device industry experience supporting manufacturing operations.
• Demonstrated ability to identify and implement process improvement opportunities.
• Experience leading cross-functional teams and driving projects to successful completion.
• Experience with CAPA, post-market quality, supplier quality, risk management and manufacturing engineering processes.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint and Outlook.
• Familiarity with manufacturing execution systems (MES), product documentation, inspection and testing methodologies.
Requisition ID: 630226
Minimum Salary: $ 78300
Maximum Salary: $ 148800
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 differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may 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.
