Senior Design Quality Engineer - Neuromodulation Systems

Boston Scientific; United States; Hybrid; USD 89,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Hybrid work model

On-site 3 days a week

Job summary

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to lead design-quality activities for neuromodulation medical-device systems, including implantable leads and surgical tools. You will partner across R&D, Regulatory, Manufacturing, and Clinical teams to embed quality throughout the product lifecycle.

The role emphasizes design controls, risk management, FMEAs, and post-market feedback, with hybrid work in California and on-site presence required three days per week.

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical, materials, systems, manufacturing engineering, or related field.
• Minimum 5 years in design quality, quality engineering, or related role in medical-device or highly regulated setting.
• Experience reviewing engineering drawings, specifications, FMEAs, risk analyses and validation evidence.

Responsibilities

• Provide quality oversight for design controls across new-product development and sustaining projects.
• Lead or support risk-management activities, including FMEAs, hazard analyses, and risk-control verification.
• Ensure design verification and validation, design transfer, and post-market feedback activities are traceable.
• Support human-factors/usability validation to meet user needs and intended uses.
• Coordinate supplier and manufacturing quality activities affecting design requirements.
• Lead CAPA, complaint investigations, and field-signal evaluations linked to risk files.
• Review post-market surveillance data to identify trends and determine corrective actions.

Skills

Quality engineering

Design controls

Risk management

Post-market surveillance

CAPA

Validation

Regulatory compliance

Education

Bachelor’s degree in biomedical, Mechanical, Electrical, Materials, Systems, Manufacturing Engineering

Tools

FMEA

ISO 13485

FDA regulations

Job description

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to lead design-quality activities for neuromodulation medical-device systems, including implantable leads and surgical tools. You will partner across R&D, Regulatory, Manufacturing, and Clinical teams to embed quality throughout the product lifecycle.

The role emphasizes design controls, risk management, FMEAs, and post-market feedback, with hybrid work in California and on-site presence required three days per week.