Senior Software V&V Lead for SaMD & SaaS

Haemonetics Software Solutions; Boston (MA); On-site; USD 103,600 - 176,400; Full time

Benefits offered by this job

401(k) with up to a 6% employer match

Employee stock purchase plan

Flexible time off

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics Software Solutions is looking for a Senior Technical Leader in Boston to define and execute Verification & Validation (V&V) strategies for Software as a Medical Device (SaMD) and SaaS platforms. The role involves ensuring compliance with FDA standards and providing technical leadership for software quality.

With 10+ years of experience, the candidate will drive quality metrics, manage test automation, and promote a culture of continuous improvement in a dynamic Agile environment. Competitive salary and comprehensive benefits are offered.

Qualifications

• 10+ years of experience executing V&V strategy for Software as a Medical Device (SaMD) and SaaS platforms.
• Hands-on experience with traceability matrices.
• Proven leadership in mentoring and guiding engineering teams.

Responsibilities

• Lead and define software V&V strategy for both non-medical and medical device software.
• Drive compliance with FDA design controls and quality management systems.
• Develop and implement robust test plans and test cases tailored to product needs.

Skills

Test automation

Quality metrics

Agile methodologies

Analytical skills

Problem-solving

Communication skills

Education

Bachelor’s or Master’s degree in Engineering, Computer Science, or related field

Tools

Compliance frameworks

Job description

Haemonetics Software Solutions is looking for a Senior Technical Leader in Boston to define and execute Verification & Validation (V&V) strategies for Software as a Medical Device (SaMD) and SaaS platforms. The role involves ensuring compliance with FDA standards and providing technical leadership for software quality.

With 10+ years of experience, the candidate will drive quality metrics, manage test automation, and promote a culture of continuous improvement in a dynamic Agile environment. Competitive salary and comprehensive benefits are offered.