Senior SaMD Software Quality Engineer

6149-DePuy Synthes Products Inc. Legal Entity; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation – 120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per year

Parental Leave – 480 hours within one年

Job summary

DePuy Synthes is seeking a Senior Quality Engineer for Product Software Development. This role leads quality on new medical device software projects and specializes in requirements gathering, software risk assessments, and test strategy definition for SaMD products.

The position requires 4+ years in regulated industries, strong collaboration with R&D, and expertise in design controls, verification, and defect analysis. Located in multiple U.S. locations with global relevance.

Qualifications

• A bachelor’s degree or university degree is required. An advanced degree is preferred.
• Degrees in Engineering, Computer Science, Information Systems, Biomedical/Bio-engineering Degree preferred.
• A minimum of 4 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required.
• The ability to apply appropriate Quality tools/systems/processes to meet departmental goals and objectives as required.
• Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required.
• Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements.

Responsibilities

• Support the design, development and testing of Medical Device Software, including SaMD products.
• Provide leadership on the software development process, procedures and practices
• Partner with R&D to refine requirements and ensure architecture/design documents are comprehensive.
• Facilitate documentation and tracking of verification activities, including code review findings.
• Review test case results and manage defects.
• Facilitate software risk assessment sessions and develop risk documents.

Skills

Team collaboration

Communication

Risk assessment

Documentation

Training / mentoring

Education

Bachelor's degree (Engineering/CS/IS)

Advanced degree preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

DePuy Synthes is seeking a Senior Quality Engineer for Product Software Development. This role leads quality on new medical device software projects and specializes in requirements gathering, software risk assessments, and test strategy definition for SaMD products.

The position requires 4+ years in regulated industries, strong collaboration with R&D, and expertise in design controls, verification, and defect analysis. Located in multiple U.S. locations with global relevance.