Embedded Software Testing

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

Experience Required: 10+ years (Minimum 5 years in medical domain)

We are seeking a highly experienced and detail-oriented Embedded Software Testing lead to join our team focused on medical device software. The ideal candidate will have a strong background in embedded systems testing, a deep understanding of medical device regulations and standards, and proven leadership in managing testing teams and strategies.

Required Qualifications:

• Lead and manage the embedded software testing team for medical device projects.
• Define and implement test strategies, plans, and procedures for embedded systems.
• Expertise in all Phases of SW testing Life cycle.
• Ensure compliance with IEC 62304, ISO 14971, ISO 13485, and other relevant medical standards.
• Collaborate with cross-functional teams including development, systems engineering, and regulatory affairs.
• Experience in Agile/Scrum methodologies.
• Exposure to Project planning/Estimation phases
• Has excellent written and oral communication skills as well as facilitation skills
• Experience or knowledge of testing complex electro-mechanical system software applications, human-machine interaction systems, or embedded systems is required.
• Writing and executing test cases ensuring that they meet provided requirements and acceptance criteria
• Ensuring consistent use of our Quality Management System tools and to document Software Verification Protocols and test results
• Follow and adhere to the best practices of software test engineering, QA practices and processes in the organization
• Provide peer review of technical and verification documents
• Ability to work effectively in a collaborative agile team environment

Preferred Qualifications:

• Experience working within a regulated environment.
• ISTQB Certification or equivalent.
• Team and Resource management experience.
• Exposure to cybersecurity standards for medical devices
• Experience working with and communicating ideas effectively in a multi-functional team of mechanical, software, and system engineers.
• Excellent attention to details.
• Strong hands-on experience working with robots, controllers, vision, safety networks, servo, I/O, integration, and instrumentations.