Senior Biomedical Engineer

Biomedical Engineer

Clinical Applications, R\&D Test/V\&V, and Vendor Support – EMS Ventilator Product Line

Location: Princeton, NJ \| Type: Full-Time \| Travel: Periodic (users/training/expos/trade shows)

Company Description

Ventis Medical is focused on improving patient outcomes in critical care situations where patients receive suboptimal care because ventilators are unavailable. The company's solution reduces barriers related to both cost and usability, making appropriate respiratory support more widely available. Team members contribute directly to technology that improves outcomes in high-acuity, time-sensitive environments.

About the Role

We're looking for a versatile Biomedical Engineer to join our team supporting our emergency and transport ventilator platform. This is a hybrid role spanning clinical education, R\&D verification \& validation (V\&V), vendor management, and field/trade-show representation. You'll work closely with clinicians, engineers, and regulatory teams to ensure our ventilator technology is well understood by users, rigorously tested, and well represented in the market.

Key Responsibilities

Clinical Applications \& Training

• Serve as clinical specialist for the VM-2000 ventilator, conducting product demonstrations for clinicians, EMS agencies, and other end users.

• Develop and deliver training programs and materials that teach safe, effective operation of the device.

• Act as a subject-matter expert on ventilator functionality, troubleshooting, and clinical workflow integration.

R\&D and Verification \& Validation (V\&V)

• Support R\&D activities across the product development lifecycle, including design verification and validation testing.

• Author and review test protocols and test reports supporting FDA submissions and software release cycles.

• Ensure V\&V documentation meets applicable regulatory standards (e.g., FDA 21 CFR 820, IEC 60601, IEC 62304) and internal quality system requirements.

• Collaborate with engineering and quality teams to identify, document, and resolve issues found during testing.

Vendor \& Supply Coordination

• Interface with vendors and suppliers to source components, products, and services needed for R\&D and production support.

• Evaluate vendor capabilities and maintain relationships that support project timelines and quality requirements.

Trade Shows \& Field Representation

• Help plan, set up, and staff company exhibits at industry expos and conferences.

• Represent the company and product line professionally to prospective customers, partners, and clinicians.

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Electrical Engineering, or related field.

• 5\+ years experience in a regulated BME position.

• Experience with medical devices, ideally respiratory/ventilation or other EMS/critical-care equipment.

• Familiarity with FDA regulatory requirements and design control / V\&V processes for medical devices.

• Familiarity with medical device quality and risk management standards (e.g., ISO 13485, ISO 14971).

• Strong technical writing skills; able to author clear, audit-ready test reports and protocols.

• Demonstrated skills in system integration, testing, data analysis, and documentation within a regulated environment.

• Comfortable presenting to and training clinical or technical audiences.

• Willingness to travel periodically for trade shows and on-site vendor or customer visits.

Preferred Qualifications

• Experience with ventilators or other Class II/III EMS devices.

• Familiarity with IEC 60601-1 and IEC 62304 standards.

• Prior experience supporting FDA 510(k) or PMA submissions.

• Experience working directly with vendors/suppliers on sourcing or procurement.

What We Offer

• Competitive salary and benefits

• Health/dental/vision, PTO

• Growth opportunities across clinical, R\&D, and field roles

To apply, please submit your resume and a brief note about your experience with medical device V\&V and/or clinical training.