Hybrid Senior Design QA Engineer, Neuromodulation

Boston Scientific Corporation; Santa Clarita (CA); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to lead quality oversight across design controls for neuromodulation medical-device systems, including implantable leads and surgical tools. This defined-term, hybrid role focuses on risk management, design verification, validation, and post-market feedback throughout the product life cycle.

The candidate will collaborate with R&D, Manufacturing, Regulatory, Clinical, Human Factors, and Project Management to ensure compliant

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical, materials, systems, manufacturing engineering or related field.
• Minimum of 5 years of experience in Design Quality, Quality Engineering, Quality Systems, Post-Market Surveillance, Risk Management, CAPA, product development, or related function in medical-device industry.
• Experience reviewing engineering drawings, specifications, tolerance analyses, test protocols/reports, FMEAs, hazard analyses, and validation evidence.
• Ability to apply risk-based judgment and translate quality/regulatory expectations into actionable requirements.
• Strong written and verbal communication and cross-functional collaboration across R&D, Manufacturing, Regulatory, Clinical, Human Factors, Marketing and Project Management.
• Working knowledge of FDA QMS Regulation and ISO 13485, ISO 14971.

Responsibilities

• Serve as the Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects (implantable leads, accessories, surgical tools).
• Provide quality oversight for risk-management activities throughout the product life cycle (planning, hazard analysis, FMEAs, residual-risk evaluation, post-production feedback).
• Support design validation and human-factors activities to ensure usability and safety across use environments.
• Oversee biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, EMC for assigned products.
• Lead or support design-change assessments, CAPA, complaint investigations, nonconformance investigations, and field-signal evaluations with risk linkage.
• Lead review of post-market surveillance data to identify risks and determine need for actions.
• Facilitate CRB activities, coordinate cross-functional contributions, analyze complaint data, and communicate outcomes.

Skills

Quality engineering

Risk management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in engineering or science

Master’s degree (preferred)

Tools

FMEAs

Design control

Job description

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to lead quality oversight across design controls for neuromodulation medical-device systems, including implantable leads and surgical tools. This defined-term, hybrid role focuses on risk management, design verification, validation, and post-market feedback throughout the product life cycle.

The candidate will collaborate with R&D, Manufacturing, Regulatory, Clinical, Human Factors, and Project Management to ensure compliant