- 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.
Skills Required
- 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
What We Do
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!
