Senior Biomedical Engineer - Regulatory & Lifecycle Leader

Ventis Medical, Inc.; Princeton (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

Ventis Medical, a Princeton, NJ-based developer of the HeroVent, seeks a Principal Biomedical Engineer with 8–10+ years of medical device experience. This on-site role leads QMSR/ISO compliance, design controls, DHF ownership, and cross‑functional collaboration with CM, suppliers, and test labs across full product lifecycle.

You will bridge advanced device design with regulatory requirements, drive V&V, risk management per ISO 14971 and IEC 60601, and guide audits and regulatory submissions

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Electrical, or a related engineering field.
• 8–10+ years of medical device engineering experience focused on Class II electromechanical devices.
• Lifecycle track record: at least one device from development through design transfer to production.

Responsibilities

• Lead design changes and features under design controls across the product lifecycle.
• Own the Design History File (DHF), requirements, design reviews, and traceability.
• Work across device architecture including pneumatics, sensors, electronics, and embedded software.
• Support FDA QMSR/ISO 13485 compliance, ISO 14971 risk management, and CAPAs.
• Plan, execute, and document V&V testing per IEC 60601-1 and ISO 80601-2-12; author protocols/reports.
• Liaise with CM, suppliers, and test labs; manage design transfer and process validation.
• Drive design-for-manufacturability and cost reductions; troubleshoot production issues.

Skills

Attention to detail

Technical writing

Communication

Education

Bachelor’s degree in Biomedical, Mechanical, Electrical, or related engineering

Job description

Ventis Medical, a Princeton, NJ-based developer of the HeroVent, seeks a Principal Biomedical Engineer with 8–10+ years of medical device experience. This on-site role leads QMSR/ISO compliance, design controls, DHF ownership, and cross‑functional collaboration with CM, suppliers, and test labs across full product lifecycle.

You will bridge advanced device design with regulatory requirements, drive V&V, risk management per ISO 14971 and IEC 60601, and guide audits and regulatory submissions