Senior Software Quality Engineer, SaMD

Biopharma Careers; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in Boston is seeking a Senior Quality Engineer, Product Software Development to lead quality activities on SaMD projects. You will drive software risk assessments, define test strategies, and mentor teams on design controls and defect analysis.

Responsibilities include supporting software development, facilitating risk sessions, coordinating verification, reviews of test results, and ensuring regulatory compliance across IEC 62304, FDA guidance, ISO 13485, and related

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Degrees in Engineering, CS, IS, or Biomedical/Bio-engineering.
• Minimum 4 years in regulated industry quality/new product development/manufacturing.
• ASQ Certification as Software Quality Engineer preferred.

Responsibilities

• Lead design, development and testing of Medical Device Software (SaMD).
• Provide leadership on software development processes and practices.
• Facilitate risk assessments and develop risk documents.

Skills

Quality engineering

Software quality

Project management

Communication

Analytical reasoning

Education

Bachelor's degree in Engineering/CS/IS/biomedical

Advanced degree preferred

Tools

SAP PLM

Job description

Johnson & Johnson in Boston is seeking a Senior Quality Engineer, Product Software Development to lead quality activities on SaMD projects. You will drive software risk assessments, define test strategies, and mentor teams on design controls and defect analysis.

Responsibilities include supporting software development, facilitating risk sessions, coordinating verification, reviews of test results, and ensuring regulatory compliance across IEC 62304, FDA guidance, ISO 13485, and related