Project Manager in Medical Device

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2

Skills

Design Review
Budget
Collaboration
Communication
Communication Planning
Cost Reduction
Leadership
Management
Medical Devices
Mentorship
Microsoft Excel
Documentation
Durable Skills
Estimating
Feasibility Study
ISO 13485
Product Design
Quality Management
Regulatory Compliance
Reporting
Research and Development
ISO 9000
Microsoft PowerPoint
Microsoft Project
Minitab
Process Flow
QMS
Statistics
Testing
Writing

Job Details

Job Title: Senior Project Manager in Medical Devices

Location: Irvine, CA

About the Role:
We are seeking a highly skilled Senior Project Manager to lead complex Capital Investment Projects (CIP) within the medical device sector. This role covers the full project lifecycle from initial quotation and budget approval through execution and validation. The ideal candidate will have a strong grasp of product design, cost-saving strategies, and regulatory compliance. You will be responsible for managing cross-functional teams and ensuring timely, on-budget delivery while maintaining compliance with all applicable regulations.

Key Responsibilities:

  • Lead and manage end-to-end Capital Investment Projects in collaboration with internal teams and external partners.

  • Conduct detailed CIP calculations, including feasibility studies, quotation analysis, capital/validation costs, and DVT sampling.

  • Define, manage, and track project budgets and timelines using Microsoft Project and PowerPoint.

  • Leverage deep product knowledge to support design improvements and supplier alternatives for Type II cost savings.

  • Develop creative strategies to achieve CIP targets and lead efforts in testing, protocol writing, and design reviews.

  • Coordinate with R&D for timeline estimates and testing requirements.

  • Oversee process validation, review of knowledge requirements, and finalization of RR and validation documentation.

  • Manage and execute change requests (CRs and SCRs).

  • Report business issues or improvement opportunities to senior leadership.

  • Ensure adherence to Health, Safety, Environmental, and regulatory guidelines at all levels.

  • Provide leadership and technical mentorship to junior team members.

  • Support team selection aligned with customer and project needs.

  • Monitor progress, track performance, and make necessary adjustments to meet project goals.

  • Serve as a key communication point across teams, leading phase/business reviews and maintaining documentation (minutes, issue logs, metrics).

Essential Skills & Qualifications:

  • Strong theoretical and practical background in engineering principles and experimentation.

  • Proficient in Quality Management Systems (QMS) and related tools.

  • Extensive knowledge of FDA regulations (21 CFR Parts 211 & 820).

  • Expert in ISO standards: ISO 13485, ISO 14971, and ISO 17025.

  • Deep understanding of medical device regulations (MDD & MDR).

  • Strong command of statistics; proficiency in Minitab is preferred.

  • Skilled in creating process flow maps and project plans (Gantt charts).

  • Exceptional communication, planning, and leadership abilities.

  • Proficiency in Microsoft Project, PowerPoint, Excel, and other MS Office tools.

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.