Additional Location(s): N/A
About this role:The Design Quality Assurance Engineer III is responsible for leading complex design-related nonconformance (NCEP) and CAPA activities across the product lifecycle. This individual will work with high-performing cross-functional development team to ensure safety, quality and compliance of our products while continuously improving their commercial value.
The position is part of the design site for the Endoscopy Division and supports activities such as NCEP/CAPA, Quality Process Improvements, and Quality Systems initiatives related to design and development.
Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week.
Relocation assistance:Relocation assistance is not available for this position at this time.
Visa sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities include: - Leads and provides quality oversight for complex design-related NCEP/CAPA activities, ensuring timely progression through all phases while maintaining compliance with regulatory and Quality System requirements.
- Leverages technical knowledge to lead teams through complex investigation and problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
- Partners with cross-functional teams to develop risk-appropriate corrective and preventive actions that effectively address identified causes and support sustainable solutions.
- Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
- Guides and mentors engineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
- Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements, internal procedures, and best quality practices.
- Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
- Supports internal and external regulatory audits as required.
What we're looking for in you:Required Qualifications
- BS in Biomedical Engineering, Mechanical Engineering or related degree.
- Minimum of 3 years of medical device engineering experience.
- Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
- Proven experience leading and owning CAPAs within the design environment, and proficiency in root cause analysis tools and methodologies.
- Travel approximately 10-20%.
Preferred Qualifications
- 5+ years of medical device engineering experience.
- Proficiency in Minitab Statistical Analysis software or equivalent.
- Six Sigma Certification.
- Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
- Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
- Proven ability to lead and coach others, driving a high-performance quality culture.
- Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.
Requisition ID: 637507Minimum Salary: $ 82100 Maximum Salary: $ 156000 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.
