Lead NPI activities for embedded software testing in medical devices, ensuring compliance with regulations, while managing teams and communicating with stakeholders.
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
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:
- Bachelor's or master's 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.
All your information will be kept confidential according to EEO guidelines.
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