Senior Product Engineer

Job Description: 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.

Role Overview

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. This is a generalist role for a seasoned professional—not a management layer. 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.

• Position Level: Principal / Senior Generalist
• Location: Princeton, NJ (Full-time, On-site)
• Reports To: CTO
• Device Classification: FDA Class II (Respiratory/Transport Ventilators)

Key Responsibilities

Product Development & Lifecycle Management

• Lead design changes and new features under design controls, managing the product smoothly from requirements through design transfer.
• Own the technical side of the Design History File (DHF), requirements, design reviews, and full traceability.
• 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 13485requirements.
• 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.
• Write technical protocols and reports that stand up to strict FDA submissions (e.g., 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.

Manufacturing & Supplier Leadership

• Act as the lead technical contact with our contract manufacturer (CM) on design transfer, process validation, yield, and scheduling.
• Resolve production line and component issues quickly, providing direct, on-the-line troubleshooting when needed.
• Drive design-for-manufacturability (DFM) improvements and proactive cost reductions.

Qualifications & Skills

Required Experience & Education

• Education: 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.
• Lifecycle Track Record: At least one device successfully taken from early development through design transfer into volume production.
• Work Environment: Full comfort working in a small, fast-paced company environment where you do the work yourself and fluidly cover multiple functions.

Technical & Regulatory Mastery

• Deep working knowledge of design controls, the newly integrated FDA QMSR framework, ISO 13485, and ISO 14971.
• 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.

Core Competencies & Soft Skills

• Meticulous Attention to Detail: A disciplined approach to reviewing fluidics, pneumatics, circuits, and extensive compliance paperwork.
• Exceptional Communication: Top-tier technical writing and verbal skills with a proven ability to write bulletproof protocols, SOPs, and technical justifications.

Nice to Have

• Direct ventilator, respiratory, anesthesia, or critical care device experience.
• Familiarity with ISO 80601-2-12 or ISO 80601-2-84.
• 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.

Details

• Employment: Full-time
• Travel: Occasional travel to the contract manufacturer, suppliers, and external test labs.
• Compensation: Competitive salary and benefits.

Ventis Medical is an equal opportunity employer.