NPD Test Lead
NPD Test Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Requirements:
- Bachelors or masters degree in computer science Electronics Biomedical Engineering or related field.
- 12 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.
- Experience with cybersecurity standards for medical devices.
- Knowledge of ISO 14971 ISO 13485 and other relevant standards.
- PMP or similar certification is a plus.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
