What are the responsibilities and job description for the Embedded Software Testing Lead (Medical Device software) position at AppLab Systems, Inc?
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.