Senior Embedded Medical Device Test Lead

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

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.