Senior Design QA Engineer – Neuromodulation (Hybrid, Valencia)

Boston Scientific Gruppe; California (MO); Hybrid; USD 89,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific seeks a Senior Design Quality Assurance Engineer in Neuromodulation to drive quality across design, development, and sustaining support for implantable devices and related tools. The role partners with R&D, Regulatory, and Manufacturing and requires hybrid work in Valencia/CA with on-site three days per week.

The position emphasizes risk management, design verification/validation, design transfer, and post-market feedback, ensuring compliance with ISO 13485/14971 and applicable

Qualifications

• Bachelor's degree in biomedical, mechanical, electrical, materials, systems, or manufacturing engineering or related field is required.
• Experience in design quality, quality engineering, quality systems, post-market surveillance, risk management, CAPA, or related function in medical devices.
• Ability to apply risk-based judgment and translate quality expectations into requirements.

Responsibilities

• Serve as the Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects involving implantable leads, accessories, and surgical tools.
• Support design-control activities ensuring user needs, inputs/outputs, reviews, verification, validation, transfer, and changes are planned and traceable.
• Provide quality oversight for risk-management activities across the product life cycle including risk analyses and control verification.
• Support design validation and human-factors activities to confirm that the device meets user needs in representative environments.
• Provide oversight for biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, EMI, and active-implantable-device evidence.
• Support supplier and manufacturing quality activities affecting design requirements or product performance.
• Lead or support design-change assessments, CAPA, complaint investigations, nonconformances, and post-market signal evaluations.
• Lead and support post-market surveillance review to identify risks and determine actions.
• Facilitate monthly Complaint Review Board (CRB) activities and distribute outcomes.

Skills

Risk-based decision making

Documentation & traceability

Communication skills

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Electrical Engineering

Bachelor's degree in Materials Engineering

Bachelor's degree in Systems Engineering

Tools

FMEA

Design Controls

ISO 13485

ISO 14971

Job description

Boston Scientific seeks a Senior Design Quality Assurance Engineer in Neuromodulation to drive quality across design, development, and sustaining support for implantable devices and related tools. The role partners with R&D, Regulatory, and Manufacturing and requires hybrid work in Valencia/CA with on-site three days per week.

The position emphasizes risk management, design verification/validation, design transfer, and post-market feedback, ensuring compliance with ISO 13485/14971 and applicable