Senior Embedded Software Test Lead - Medical Devices

TechDigital Group; Milpitas (CA); On-site; USD 140,000 - 170,000; Full time

Job summary

TechDigital Group seeks an experienced Embedded Software Testing Lead to guide a team focused on medical device software. You will shape testing strategy, ensure IEC 62304/ISO 14971/ISO 13485 compliance, and collaborate closely with development and regulatory teams to deliver safe, high-quality products.

You will drive test plans, mentor testers, and oversee verification activities in an agile environment, ensuring robust documentation and process improvements across projects.

Qualifications

• 10+ years embedded software testing experience in medical devices.
• Strong knowledge of IEC 62304, ISO 14971 and ISO 13485 requirements.
• Proven leadership of testing teams and test strategy development.
• Experience with Agile/Scrum and cross-functional collaboration.

Responsibilities

• Lead and manage the embedded software testing team for medical device projects.
• Define and implement test strategies, plans, and procedures for embedded systems.
• Ensure compliance with medical standards across all phases of testing.
• Collaborate with development, systems engineering and regulatory affairs.
• Drive quality through rigorous test case design and documentation.

Skills

Embedded testing

Medical devices standards

IEC 62304

ISO 14971

ISO 13485

Agile/Scrum

Leadership

Test strategies

Verification & validation

Documentation

Communication skills

Job description

TechDigital Group seeks an experienced Embedded Software Testing Lead to guide a team focused on medical device software. You will shape testing strategy, ensure IEC 62304/ISO 14971/ISO 13485 compliance, and collaborate closely with development and regulatory teams to deliver safe, high-quality products.

You will drive test plans, mentor testers, and oversee verification activities in an agile environment, ensuring robust documentation and process improvements across projects.