NPI Project Engineer — Medical Devices

Koch; Costa Mesa (CA); On-site; USD 105,000 - 120,000; Full time

Job summary

Phillips Medisize in Costa Mesa, CA is seeking a Project Engineer to independently lead moderately complex NPI and sustaining projects from initiation through production release. You will align customer requirements with manufacturing readiness and ensure disciplined planning and risk management.

You will work with engineering, manufacturing, quality, validation, regulatory, supply chain, and operations teams to deliver successful project outcomes and maintain audit-ready records.

Qualifications

• Bachelor's degree in engineering required.
• 5+ years of project engineering, program execution, or equivalent leadership experience.
• Experience leading NPI or sustaining projects from initiation to production release.
• Experience managing project schedules, milestones, dependencies, actions, risks, and stage-gate deliverables.

Responsibilities

• Lead assigned NPI and sustaining projects or support Program Management based on project scope and business needs.
• Own integrated project plans, including schedules, milestones, dependencies, actions, risks, stage-gate readiness, and project-status reporting.
• Coordinate cross-functional contributors and facilitate readiness reviews while maintaining ownership of technical decisions and approvals.
• Communicate project status, commitments, risks, decisions, barriers, and recovery plans to internal teams, customers, suppliers, and other stakeholders.
• Connect customer requirements with manufacturing readiness and quality, validation, regulatory, supply, operational, and commercial considerations.
• Maintain traceable, audit-ready project records, objective evidence, required deliverables, open items, and approved exceptions.
• Promote safety, ergonomics, standard work, continuous improvement, lessons learned, and practices that improve project predictability.

Skills

Project management

Cross-functional collaboration

Risk management

Communication

Education

Bachelor's degree in engineering

Bachelor's degree in mechanical engineering

Tools

SolidWorks

Job description

Phillips Medisize in Costa Mesa, CA is seeking a Project Engineer to independently lead moderately complex NPI and sustaining projects from initiation through production release. You will align customer requirements with manufacturing readiness and ensure disciplined planning and risk management.

You will work with engineering, manufacturing, quality, validation, regulatory, supply chain, and operations teams to deliver successful project outcomes and maintain audit-ready records.