Experience Required: 10+ years (Minimum 5 years in medical domain)
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.
Numbers & Facts
Location
Milpitas, CA
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Agile Programming Methodologiesunmatched
Best Practicesunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Electromechanical Systemsunmatched
Embedded Softwareunmatched
Embedded Systemsunmatched
Healthcare Softwareunmatched
Human Interactionunmatched
ISO (International Organization for Standardization)unmatched
ISTQB Foundationunmatched
Input/Outputunmatched
International Electro-Technical Commission (IEC)unmatched
Internet Securityunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Medical Protocolsunmatched
Presentation/Verbal Skillsunmatched
Project Estimatesunmatched
Project Planningunmatched
Quality Assurance Methodologyunmatched
Quality Managementunmatched
Regulationsunmatched
Resource Managementunmatched
Scrum Project Management and Software Developmentunmatched
Servomechanismunmatched
Software Engineeringunmatched
Software Testingunmatched
Strategic Planningunmatched
System Testunmatched
Systems Engineeringunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Technical Writingunmatched
Test Caseunmatched
Test Plan/Scheduleunmatched
Test Strategyunmatched
Testingunmatched
Writing Skillsunmatched
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