Test Lead - Functional Testing

Sapsf; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Sapsf is seeking a highly experienced Test Lead for Functional Testing of embedded medical device software. The role emphasizes rigorous testing across the software life cycle and regulatory compliance.

You will lead test planning, design, execution, and defect review in an Agile environment, collaborating with development, systems engineering, and regulatory affairs to ensure patient safety and product quality.

Qualifications

• 8–10 years of embedded software testing experience in medical devices.
• Strong knowledge of IEC 62304, ISO 14971, and ISO 13485.
• Experience with cybersecurity patches and OS updates in regulated environments.
• Experience in Agile/Scrum environments.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead test planning, design, execution, and defect review.
• Ensure compliance with medical device standards and regulatory requirements.
• Coordinate with development, systems engineering, and regulatory affairs.
• Perform installation qualification and regression testing.
• Mentor junior testers and promote QA best practices.

Skills

Embedded testing

Manual testing

Regulatory compliance

Agile/Scrum

System/Software testing

Education

ISTQB Certification or equivalent

Tools

Quality Management System tools

Job description

Career Opportunities: Test Lead - Functional Testing (179844)

Requisition ID179844-Posted10/14/2026

We are seeking a highly experienced and detail-oriented Embedded Software Testing engineer with 8-10 yrs of experience to join our team focused on medical device software.

Key Responsibilities

The ideal candidate will have a strong background in embedded systems testing, a deep understanding of medical device regulations and standards.

Skill Requirements

• Expertise in all Phases of SW testing Life cycle. Test Planning, Test case design, Test cases writing, Test case review and test results reviews, Defect Logging, Defect Analysis. Regression testing
• Experience in Manual testing – Medical devices
• Expertise in system and SW testing
• Validate cybersecurity patches, hotfixes, security updates, and operating system updates in regulated medical device environments.
• Perform installation qualification, patch deployment verification, regression testing, and compatibility testing.
• 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.
• 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.

IT experience a plus especially with Windows 2000

• 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

Other Requirements

• Experience working within a regulated environment.
• ISTQB Certification or equivalent.
• 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.