Project Manager

6 days ago


Lancaster, Pennsylvania, United States MDI-llc Full time

Project Manager/Project Engineer – Medical Device Manufacturing

Location: Lancaster, PA

Job Type: Full-Time

Experience Level: Mid-Level

Job Summary

We are seeking a motivated Project Engineer / Project Manager to support and lead projects within our medical device manufacturing operations. This role is responsible for managing cross-functional projects from concept through production, ensuring compliance with regulatory requirements, timelines, budgets, and quality standards.

The ideal candidate has a strong technical background, excellent organizational skills, and experience working in a regulated manufacturing environment.

Key Responsibilities

  • Plan, manage, and execute engineering and manufacturing projects related to medical devices
  • Lead cross-functional teams including Engineering, Quality, Manufacturing, Supply Chain, and Regulatory
  • Develop and maintain project plans, schedules, budgets, and risk assessments
  • Coordinate product development, process improvements, equipment validation, and manufacturing transfers
  • Ensure compliance with FDA regulations, ISO 13485, GMP, and internal quality systems
  • Support design controls, process validation (IQ/OQ/PQ), and change management activities
  • Track project progress, identify risks, and communicate status to stakeholders and leadership
  • Support continuous improvement initiatives to improve quality, cost, and delivery

Required Qualifications

  • Bachelor's degree in Engineering (Mechanical, Biomedical, Manufacturing, Industrial, or related field)
  • 3+ years of experience in project engineering or project management within a manufacturing environment
  • Experience in a regulated industry (medical device preferred; pharma/aerospace acceptable)
  • Strong understanding of project management principles and tools
  • Excellent communication, organization, and problem-solving skills

Preferred Qualifications

  • Experience with medical device manufacturing and FDA regulations
  • Knowledge of ISO 13485, Design Controls, and GMP requirements
  • Experience with validation, process development, or equipment implementation
  • Project Management certification (PMP or similar) is a plus

Benefits

  • Competitive salary
  • Health, dental, and vision insurance
  • 401(k) with company match
  • Paid time off and holidays
  • Opportunities for professional growth in a regulated medical device environment

Job Types: Full-time, Permanent

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Relocation assistance

Work Location: In person


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