NPD Test Lead- Embedded systems, Mobile app (Medical Device domain)

Company Description

We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.

Job Description

NPD Test Lead- Embedded systems, Mobile app  to drive the Test strategy , test automation  and 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 testing  in medical devices.
• Oversee Test protocols, test strategy and test automation  testing aligned with IEC 62304 standards.
• Manage and troubleshoot communication protocols including BLE, Serial, SPI, UART.
• Utilize protocol sniffers and debugging tools to resolve technical issues.
• Ensure compliance with FDA guidelines, SaMD testing protocols, and other regulatory standards.
• Collaborate with cross-functional teams across onsite and offshore locations to resolve technical challenges.
• Drive Software 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.
• 14+ years of experience in embedded software development and testing for medical devices
• Experience with Appium or any other mobile test automation framework
• Strong understanding of IEC 62304, FDA regulations, and SaMD standards.
• Hands-on experience with BLE, Serial, SPI, UART communication protocols.
• Proficiency in using protocol sniffers and debugging tools.
• Proven experience managing offshore and onsite teams.
• Excellent communication, leadership, and problem-solving skills.
• Familiarity with STLC, 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.

Regards,

Mohammed Ilyas,

PH - 229-264-4024 or Text - 229-469-1455 or you can share the updated resume at Mohammed@vtekis. com 

Additional Information

All your information will be kept confidential according to EEO guidelines.