Senior Quality Engineer, Medical Device Software

Johnson and Johnson; Boston (MA); Vor Ort; USD 109.000 - 175.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Senior Quality Engineer for Product Software Development to lead quality activities on medical device software projects. The role focuses on requirements gathering, risk assessments, test strategy, and design controls, with responsibilities spanning audits, CAPAs, and regulatory support.

Ideal candidates have 4+ years in regulated quality or NPD, a strong understanding of IEC 62304 and ISO13485, and a commitment to mentoring engineers while ensuring patient data

Qualifikationen

• Bachelor's or higher in Engineering, Computer Science, or related field.
• Advanced degree preferred for higher responsibility.
• 4+ years in regulated industry quality, NPD, or manufacturing engineering.
• Ability to apply quality tools/systems to meet goals.
• Prioritization and multi-project management capability.

Aufgaben

• Lead software quality on medical device software development projects.
• Guide requirements gathering and risk assessments.
• Define test strategies and design controls for SaMD.
• Support regulatory filings and product audits.
• Mentor junior engineers and share quality best practices.
• Ensure compliance with IEC 62304, ISO 13485, FDA/FDA 11 guidance.

Kenntnisse

Analytical Reasoning

Coaching

Collaboration

Critical Thinking

MBSE

Product Design

Report Writing

Requirements Analysis

SDLC

SQA

Ausbildung

Engineering degree

Advanced degree preferred

Tools

SAP PLM

Jobbeschreibung

Johnson & Johnson is seeking a Senior Quality Engineer for Product Software Development to lead quality activities on medical device software projects. The role focuses on requirements gathering, risk assessments, test strategy, and design controls, with responsibilities spanning audits, CAPAs, and regulatory support.

Ideal candidates have 4+ years in regulated quality or NPD, a strong understanding of IEC 62304 and ISO13485, and a commitment to mentoring engineers while ensuring patient data