Full-Time
NPD Test Lead
Katalyst Healthcares & Life Sciences
51-200 employees
Clinical trial management software and services
No salary listed
Burlington, MA, USA
In Person
 QA & Testing (2) |
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- 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
- 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
- PMP or similar certification is a plus
Katalyst Healthcares & Life Sciences provides a Clinical Trial Management Solution called EasyCDM Suite that covers the full lifecycle of clinical trials. The product supports study design, data capture, medical coding, and data management to streamline processes for clients in pharmaceutical, biopharmaceutical, medical device, cosmeceuticals, and food and beverage industries. The system works by organizing trial data in a unified platform, enabling electronic data capture (EDC), coding, data validation, and workflow management, while consulting services assist with implementation and optimization. The company differentiates itself through a combined offering of software, consulting, and services that aim to accelerate drug development while maintaining quality and safety standards. The goal is to simplify business challenges, maximize human potential, and improve health outcomes worldwide through life science innovations.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
South Plainfield, New Jersey
Founded
2016
Simplify's Take
What believers are saying
- Hiring 735 positions signals strong contract staffing expansion.
- Global CRO services enhance competitive positioning worldwide.
- Active jobs in Burlington MA, Newark NJ, San Diego CA diversify geography.
What critics are saying
- Medidata Rave and Veeva Vault erode EasyCDM sales in 12-24 months.
- FDA 2025 AI mandate forces EasyCDM upgrades or client loss in 6-12 months.
- Oracle-Certara acquisition outcompetes consulting contracts in 18-24 months.
What makes Katalyst Healthcares & Life Sciences unique
- EasyCDM Suite streamlines clinical trials from study design to data management.
- Serves pharmaceutical, biopharma, medical devices, cosmeceuticals, and food sectors.
- Combines consulting services with EasyCDM for accelerated drug development.
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