Embedded Test Lead
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Position- Embedded Test Lead- Embedded systems, Mobile app (5 days per weekonsite )

Location: Burlington, MA (Need candidates from East coast who are OK to relocate.)

Note-Must to have Medical Device background

Embedded Test Lead- Embedded systems, Mobile app to drive the Test strategy , test automationand introduction of cutting-edge medical devices . This role demands deep technical expertise in embedded software,Mobile test automation, regulatory compliance, and cross-functional leadership to ensure successful product launches in a highly regulated environment.

Key Responsibilities:

• Lead end-to-end NPI activities for embedded software testingin medical devices .
• Oversee Test protocols, test strategy and test automationtesting aligned withIEC 62304standards.
• Manage and troubleshoot communication protocols includingBLE, Serial, SPI, UART.
• Utilize protocol sniffers and debugging tools to resolve technical issues.
• Ensure compliance withFDA guidelines,SaMDtesting protocols, and other regulatory standards.
• Collaborate with cross-functional teams acrossonsite and offshorelocations to resolve technical challenges.
• DriveSoftware Testing Life Cycle (STLC)processes and ensure quality assurance.
• Interface with regulatory bodies and support documentation for audits and submissions.
• Communicate effectively with stakeholders, including engineering, QA, regulatory, and product teams.

Required Qualifications:

• Bachelor's or Master's degree in Computer Science, Electronics, Biomedical Engineering, or related field.
• 1 2 + years of experience in embedded software development and testing for medical devices
• Experience with Appium or any other mobile test automation framework
• Strong understanding ofIEC 62304,FDA regulations, andSaMDstandards.
• Hands-on experience withBLE, Serial, SPI, UARTcommunication protocols.
• Proficiency in usingprotocol sniffersand debugging tools.
• Proven experience managingoffshore and onsite teams.
• Excellent communication, leadership, and problem-solving skills.
• Familiarity withSTLC, risk management, and design controls.

Preferred Qualifications:

• Experience with cybersecurity standards for medical devices.
• Knowledge of ISO 14971, ISO 13485, and other relevant standards.
• PMP or similar certification is a plus.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeContract

Job function

• Job functionQuality Assurance
• IndustriesIT Services and IT Consulting

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