Senior Product Engineer, Applications

Principal Biomedical Engineer (Quality, Regulatory & Lifecycle)  About Ventis Medical Ventis Medical is a Princeton, NJ company that makes the HeroVent , a class-leading, FDA-cleared emergency and transport ventilator . The HeroVent is compact, rugged, and built for EMS, fire, and military first responders who need to deliver precise ventilation in the field. We are a small, cross-functional team where everyone works close to the product, the customer, and each other.   We are seeking a detail-oriented, hands-on Principal Biomedical Engineer with 8–10+ years of experience to serve as the senior technical owner of the HeroVent across its full lifecycle. You will work closely with the leadership team on-site in Princeton and act as the lead technical contact for our contract manufacturer, suppliers, and test labs. The ideal candidate bridges the gap between advanced medical device design and strict regulatory requirements, possessing deep expertise in FDA Quality Management System Regulation (QMSR) and exceptional communication skills to handle complex engineering data, technical writing, and audit defenses. Princeton, NJ (Full-time, On-site) Product Development & Lifecycle Management Work across the entire device architecture, including pneumatics, turbines, sensors, electronics, and embedded software interfaces.   QMSR, Quality & Regulatory Compliance Help maintain the quality management system to FDA QMSR (21 CFR Part 820) and ISO 13485 requirements. Maintain risk management systems to ISO 14971 , creating and updating FMEAs and Risk Management Reports to support regulatory submissions. Lead rigorous root cause investigations, Corrective and Preventive Actions ( CAPA ), nonconformances, and complaint investigations. 510(k)) and external regulatory audits.   Testing, Verification & Validation Plan, run, and document verification and validation (V&V) testing to ISO 80601-2-12 and the IEC 60601 series. Design and maintain in-house test fixtures while managing relationships and compliance with outside test labs.   Act as the lead technical contact with our contract manufacturer (CM) on design transfer, process validation, yield, and scheduling. Bachelor's degree in Biomedical, Mechanical, Electrical, or a related engineering field. Experience: 8–10+ years of medical device engineering experience focused on Class II electromechanical devices . Technical & Regulatory Mastery Hands-on V&V testing experience, including authoring protocols/reports and testing to IEC 60601-1 . Direct experience managing contract manufacturers or critical technical suppliers.   Exceptional Communication: Top-tier technical writing and verbal skills with a proven ability to write bulletproof protocols, SOPs, and technical justifications.   Experience with the IEC 62304 software lifecycle. Experience writing 510(k) content or responding directly to FDA Requests for Additional Information (AI). Ruggedized or military product experience, including environmental and transport testing.

Employment: Full-time Travel: Occasional travel to the contract manufacturer, suppliers, and external test labs. Ventis Medical is an equal opportunity employer.