Project Manager - Medical Device

Project Manager (Medical Device / FDA Environment)

Location: Remote (Periodic onsite in Columbus, OH – ~1x/month initially)

Engagement: Part-Time (~20–25 hours/week) - TBD based on intended milestones and needs

Overview

We are seeking a hands-on Project Manager to help drive execution across a fast-moving, early-stage medical device environment. This role will bring structure, visibility, and accountability to cross-functional initiatives, ensuring projects stay on track while aligning with FDA and quality system expectations.

This is a remote part-time/fractional role with nominal 20-25 hours per week anticipated.

Key Responsibilities

Establish and maintain a single integrated project schedule across engineering, clinical, quality, and regulatory teams, serving as the “schedule of truth” that aligns priorities, milestones, and dependencies.

Lead recurring milestone and status meetings, ensuring risks, timelines, and cross-functional dependencies are clearly understood, while driving follow-through, documentation readiness, and timely decision-making across the organization.

Coordinate execution across teams, integrating inputs from hardware and software development efforts, including interfacing with Jira to understand software progress, track issues, and reflect updates in overall project plans.

Support execution within an FDA-regulated environment by aligning project activities with design controls, DHF documentation, and change management processes within the QMS.

Introduce and apply structured project management methodologies (PMP, Lean, Six Sigma, or similar) to improve visibility, reduce schedule slippage, and build scalable operating rhythms appropriate for a startup environment.

Preferred Experience

Experience managing projects in medical device or FDA-regulated environments, with familiarity in design controls, DHF processes, and ISO 13485. Background supporting both software and hardware development efforts is preferred, particularly in electromechanical or software-containing products. Experience working in early-stage or evolving environments is highly valued.

Profile

An organized, proactive project manager who can bring structure without over engineering process, operate effectively in ambiguity, and keep cross-functional teams aligned and moving forward in a regulated environment.

Engagement

Approximately 20–25 hours per week, primarily remote, with occasional onsite presence (1/month) early on to build alignment and relationships with the team.