Project Engineer / Program Manager Medical Devices

Overview

On Site
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)

Skills

Medical devices
ISO 13485
MS Project
PMP
PROJECT ENGINEER
SmartSheet
or Jira

Job Details

Overview
We are seeking a Program Manager (Project Engineer) to lead innovative medical device projects from concept through commercial launch. This role blends engineering expertise with program management skills to deliver safe, effective, and compliant products - on time, within budget, and to the highest quality standards.

Key Responsibilities

  • Lead cross-functional teams (R&D, Quality, Regulatory, Manufacturing) through the full product lifecycle in compliance with ISO 13485 and FDA design controls.

  • Develop and manage project plans, budgets, schedules, and risk registers.

  • Facilitate design reviews, technical problem-solving, and product verification/validation activities.

  • Ensure adherence to regulatory and quality requirements, preparing documentation for regulatory submissions.

  • Monitor progress, manage risks, and present updates and solutions to stakeholders.

Qualifications

  • Bachelor's degree in Mechanical, Biomedical, Electrical, or related engineering discipline (Master's preferred).

  • 5+ years of experience in medical device development, including 3+ years in program or project management.

  • Strong knowledge of design controls, risk management (ISO 14971), and global regulatory standards.

  • Proficiency in project management tools such as MS Project, Smartsheet, or Jira.

  • Exceptional leadership, communication, and analytical problem-solving skills.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

About Intellectt INC