NPD Test Lead- Embedded systems, Mobile app (Medical Device domain)
NPD Test Lead- Embedded systems, Mobile app (Medical Device domain)
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Salary Not Disclosed
1 Vacancy
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:
- Bachelors or Masters 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 - or Text - or you can share the updated resume at com
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
