Embedded Software Testing Lead (Medical Device software)

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

Job Title: Embedded Software Testing Lead

Location: Milpitas, CA ( 5 Days onsite)

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

Job Summary:

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.