Embedded Software Testing Lead — Medical Devices

AppLab Systems, Inc; Milpitas (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

AppLab Systems, Inc. in Milpitas, CA seeks an experienced Embedded Software Testing Lead to drive validation and verification of medical device software.

You will lead a testing team, define test strategies, and ensure regulatory compliance. You will partner with development, systems engineering, and regulatory affairs to implement robust test plans, execute test cases, and document verification protocols in our Quality Management System.

Qualifications

• Experience leading embedded software testing teams for medical device projects.
• Ability to define and implement test strategies, plans and procedures for embedded systems.
• Experience across all phases of the software testing life cycle.
• Familiarity with IEC 62304, ISO 14971, ISO 13485 and other medical standards.
• Strong written and oral communication and facilitation skills.

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 IEC 62304, ISO 14971, ISO 13485, and other medical standards.
• Collaborate with cross-functional teams including development, systems engineering, and regulatory affairs.
• Write and execute test cases meeting requirements and acceptance criteria.

Skills

Embedded testing leadership

Test strategy development

Agile/Scrum experience

Communication skills

Cross-functional collaboration

Tools

ISTQB Certification

Job description

AppLab Systems, Inc. in Milpitas, CA seeks an experienced Embedded Software Testing Lead to drive validation and verification of medical device software.

You will lead a testing team, define test strategies, and ensure regulatory compliance. You will partner with development, systems engineering, and regulatory affairs to implement robust test plans, execute test cases, and document verification protocols in our Quality Management System.