Senior Design Quality Assurance Engineer - Neuromodulation; NALU

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Onsite Location(s):
Valencia, CA, US, 91355

Additional Location(s): 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 Senior Design Quality Assurance Engineer serves as a key Quality representative for the design, development, integration, and sustaining support of Neuromodulation medical-device systems. The role emphasizes external equipment, implantable leads, accessories, and surgical tools.

This engineer partners with R&D, Systems Engineering, Manufacturing, Supplier Engineering, Regulatory Affairs, Clinical, Human Factors, and Project Management to build quality into products throughout the product life cycle. The position provides independent quality oversight of design controls, risk management, design verification and validation, design transfer, change assessment, and post-market feedback.

This is a defined-term, hybrid position preferably based in Valencia, California (or California in general), with periodic on-site presence aligned to business and project needs.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Valencia or Carlsbad, CA and requires being on-site at least three (3) days per week.

Relocation assistance:

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

• Serve as the Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects involving implantable leads, accessories, and surgical tools.
• Support cross-functional teams through applicable design-control activities, ensuring user needs, design inputs, design outputs, design reviews, verification, validation, design transfer, and design changes are appropriately planned, executed, documented, and traceable.
• Provide quality oversight for risk-management activities throughout the product life cycle, including risk-management planning, preliminary hazard analysis, system and component hazard analyses, design FMEAs, use-related risk analysis, risk-control verification, residual-risk evaluation, and production/post-production feedback.
• Support design validation and human-factors activities to confirm that the finished device, accessories, labeling, packaging, and use workflows meet user needs and intended uses in representative use environments.
• Providing quality oversight for biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, electromagnetic compatibility, and active-implantable-device evidence, as applicable to the assigned products and changes.
• Support supplier and manufacturing quality activities that affect design requirements or product performance, including component qualification, supplier changes, nonconformance investigations, process validation, design transfer, and production-readiness reviews.
• Lead or support design-change assessments, CAPA, complaint investigations, nonconformance investigations, and field-signal evaluations by connecting post-market evidence to risk files, requirements, verification evidence, and potential corrective actions.
• Lead and…