NPD Test Lead- Embedded systems, Mobile app

Burlington - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position- NPD Test Lead- Embedded systems Mobile app (5 days per week onsite )
Location: Burlington MA (Need candidates from East coast who are OK to relocate.)
Type: Contract

Note- Must to have Medical Device background

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:

Bachelors or Masters degree in Computer Science Electronics Biomedical Engineering or related field.
12 years of experience in embedded software testing for medical devices
Experience with Appium or any other mobile test automation framework
Strong understanding of IEC 62304 FDA regulations and SaMD standards.
Knowledge 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:

Knowledge of ISO 14971 ISO 13485 and other relevant standards.
PMP or similar certification is a plus.

Position- NPD Test Lead- Embedded systems Mobile app (5 days per week onsite ) Location: Burlington MA (Need candidates from East coast who are OK to relocate.) Type: Contract Note- Must to have Medical Device background NPD Test Lead- Embedded systems Mobile app to drive the Test strategy test au...

Position- NPD Test Lead- Embedded systems Mobile app (5 days per week onsite )
Location: Burlington MA (Need candidates from East coast who are OK to relocate.)
Type: Contract

Note- Must to have Medical Device background

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:

Bachelors or Masters degree in Computer Science Electronics Biomedical Engineering or related field.
12 years of experience in embedded software testing for medical devices
Experience with Appium or any other mobile test automation framework
Strong understanding of IEC 62304 FDA regulations and SaMD standards.
Knowledge 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: