Principal Design Quality Assurance Engineer - Endoscopy

Additional Location(s): US-MA-Marlborough; N/A

Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance

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.

The Principal Design Quality Assurance Engineer isa seasonedprofessional withexperiencein quality engineering and regulatory requirements for the medical device industry.

This role serves as a driving force in the quality department, championing excellence, compliance, and continuous improvement across projects and teams.

Thepositionis part of the design site for the Endoscopy Division andsupportsactivities such as New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.

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 may be 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.

• Acts as the primary voice for quality within cross-functional teams, influencing projectdirection and ensuring adherence to regulatory requirements and best practices.
• Leadsthe execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Leadsthe execution of the Risk Management deliverables to ensure compliancetoISO 14971 anddemonstratesa primary commitment to patient safety.
  
  Guides the successful completion of major programs and may function in a project leadership role.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the companyutilizingcross-functional resources.
  
  Actsas division representative on cross-divisional projects defining the quality system(s).
• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Appliessystematic approaches (e.g.5 Whys, Is-Is Not, DMAICand Six Sigmaproblem solving methodologies) to diagnose root causes,optimize processes, and ensure sustained corrective actions.
• Guides andmentorsengineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders.
  
  Usesinfluence and negotiation skills to integrate quality perspectives into business decisions.
• Identifies and implements best-in-class practices forthe department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
• Supportsinternal and external regulatory audits asauditfacing subject matterexpertasrequired.
  
  Supports regulatory responses through technical writing and submission consultation as required.

Required Qualifications

• BS inBiomedical
  
  Engineering,Mechanical Engineeringor related degree.
• 8+ yearsofmedical deviceengineering experience.
• In-depth knowledge of US and Internationalmedical devicerequirementsincluding 21 CFR part 820, Medical Device Directive(MDD)/ Medical Device Regulation(EU MDR), EN ISO 13485 and EN ISO 14971.
• Travelapproximately
  10-20%.

Preferred Qualifications

• 10+ years of medical device engineeringexperience.
• Sustaining Experience
• NPDExperience
• Expertise in Usabilityand Human  Factors engineering.
• Proficiency in Minitab Statistical Analysis software or equivalent.
• Six Sigma Black Belt Certification.

Requisition

Minimum Salary:$97000

Maximum Salary: $184300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see  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…