Project Manager - Combination Product

Job Description

Role Overview

The Technical Project Manager supports medical device and drug-device combination product development programs (e.g., auto‑injectors, prefilled syringes, on‑body injectors). This role focuses on managing Design History File (DHF) documentation, coordinating cross‑functional technical activities, and maintaining project timelines within a regulated environment.

Key Duties & Responsibilities

• Lead multiple device/combination product projects with a discrete technical focus (e.g., auto‑injectors, injection pens, on‑body injectors, prefilled syringes).
• Manage and coordinate Design History File (DHF) documentation, including compilation, tracking, and ensuring completeness of required documentation packages.
• Develop and maintain detailed project timelines and work plans to support device development deliverables.
• Partner cross‑functionally with engineering, quality, regulatory, and other technical teams to drive project execution and alignment.
• Identify, assess, and proactively communicate project risks, gaps, and documentation deficiencies, providing recommendations for resolution.
• Track progress across multiple concurrent projects and adjust plans as needed to meet development milestones.
• Facilitate project meetings, document action items, and ensure follow‑through on commitments.
• Support elements of technical project management, including documentation workflows and coordination of device‑related deliverables.
• Contribute to process improvements and best practices within the combination product/device function.

Required Education

• Typically requires a Bachelor's degree in a project management or related discipline.

Required Experience

• Typically requires 5+ years of relevant experience in medical device or drug-device combination product development.
• Demonstrated experience supporting or managing device development programs (e.g., auto‑injectors, injection systems, prefilled syringes, on‑body delivery systems).
• Experience compiling or managing Design History File (DHF) documentation strongly preferred.
• Experience working cross‑functionally in regulated environments required.

Required Knowledge & Skills

• Strong understanding of medical device development processes and documentation requirements.
• Working knowledge of combination product development considerations.
• Experience managing multiple concurrent technical projects in a regulated environment.
• Ability to independently organize and manage documentation packages with high attention to detail.
• Strong project planning and timeline management skills.
• Direct, confident communication style with the ability to work effectively across technical teams.
• Ability to operate with limited oversight and quickly integrate into established development programs.

Contract Length: Through the end of the year.

$80/hr.

- $90/hr.

Monday - Friday