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Technical Project Manager - Next Generation Ventilator Program

Enexor BioEnergy

Franklin, TNJobPosted 4 days agoStill listed 3 days ago

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At a glance

Compensation
No compensation found
Location
Franklin, TN
Work Authorization
Not specified

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Job overview

Enexor BioEnergy seeks a Technical Project Manager to lead end‑to‑end development of a Class II ventilator, coordinating mechanical, electrical, firmware, industrial design, manufacturing and regulatory teams while driving schedule, risk, and deliverables in a fast‑paced, hands‑on medtech environment.

Skills & qualifications

RequiredNice to have

Skills

Software Project ManagementRisk ManagementNew Product DevelopmentOrganizational SkillsProblem SolvingISO 13485PrototypingTechnical LiteracyOrganizational DisciplineHigh Ownership MindsetIEC 60601FDA 510(K) ProcessesLab TestingElectromechanical SystemsEmbedded Hardware

Qualifications

Engineering Background (ME, EE, BME, CompE)Up to Five Years Product Development ExperienceExposure to Electromechanical Systems or Embedded HardwareFamiliarity With ISO 13485, IEC 60601, Risk Management, FDA 510(K) ProcessesExperience With Prototyping, Lab Testing, Hands‑on Engineering Work

Benefits

Medical Insurance
401(k) Match
Paid Time Off

Full job description

About Us We are an early-stage company developing disruptive medical technologies that challenge industry norms and dramatically reduce cost and complexity. Our small, hands-on team designs, builds, and validates next-generation medical devices entirely in-house from concept through FDA submission. If you are motivated by complex problems, rapid iteration, and creating products that make a real impact, this is the place where your work will matter every day. The Opportunity We are recruiting a Technical Project Manager to drive the end-to-end development of a new Class II ventilator. You will be the connective tissue across mechanical, electrical, firmware, industrial design, manufacturing, and regulatory teams, keeping the program aligned, moving forward, and delivering results. We are not looking for a career PM who hides behind process. We want a sharp, driven engineer who thrives on ownership, clarity, and execution. If you can think like an engineer but operate like a program leader, you will excel in this role. What You Will Do

  • Own day-to-day program execution, including schedule, risk management, deliverables, and cross-team coordination

  • Translate product requirements into actionable engineering workstreams and hold teams accountable.

  • Design reviews, maintain the engineering backlog, and drive decision-making with incomplete information.

  • Coordinate closely with mechanical, electrical, firmware, and industrial design teams to integrate subsystems.

  • Manage vendor interactions, including ID and UX firms, PCB vendors, plastics suppliers, sensor suppliers, test labs, and manufacturing partners.

  • Ensure documentation, DMR, and DHF organization, traceability, and test readiness in accordance with FDA design controls.

  • Support prototyping, V and V planning, test execution, and system integration when needed. This role is hands-on.

What We Are Looking For

  • Engineering background, such as ME, EE, BME, CompE, or related field

  • Strong technical literacy and the ability to interface directly with engineering teams

  • Excellent organizational discipline and a bias for clarity, simplification, and forward progress

  • High ownership mindset and a willingness to run toward problems

Ability to thrive in a fast-paced, highly collaborative, high-expectation environment

Preferred Experience We will take horsepower over years of experience. Up to five years of experience in product development or technical project work

Exposure to electromechanical systems or embedded hardware

Familiarity with ISO 13485, IEC 60601, risk management, or FDA 510(k) processes

Experience with prototyping, lab testing, or hands-on engineering work

What We Offer

  • A front row seat in a fast-growing, mission-driven medtech company
  • Competitive salary and equity opportunity
  • Health insurance stipend, QSEHRA, and 401(k).

Paid PTO and holidays

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