Med Device NPI Project Lead

Koch Business Solutions, LP; Costa Mesa (CA); Presencial; USD 105 000 - 120 000; Tempo integral

Resumo da oferta

Koch Business Solutions, LP in Costa Mesa, CA seeks a Project Engineer to lead moderately complex NPI and sustaining projects from initiation through production release. You will connect customer requirements with manufacturing readiness, quality, validation, regulatory, and commercial needs while aligning with business priorities.

The role emphasizes disciplined planning, risk management, and execution, with collaboration across engineering, manufacturing, quality, regulatory, supply chain, and

Qualificações

• 5+ years of project engineering, program execution, or comparable engineering project leadership experience.
• Experience leading new product introduction or sustaining projects from initiation through production release.
• Experience managing project schedules, milestones, dependencies, actions, risks, and stage-gate deliverables.

Responsabilidades

• 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 clear 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.

Conhecimentos

Project leadership

NPI experience

Medical device industry

Cross-functional collaboration

Formação académica

Bachelor's degree in mechanical engineering

Ferramentas

SolidWorks

Descrição da oferta de emprego

Koch Business Solutions, LP in Costa Mesa, CA seeks a Project Engineer to lead moderately complex NPI and sustaining projects from initiation through production release. You will connect customer requirements with manufacturing readiness, quality, validation, regulatory, and commercial needs while aligning with business priorities.

The role emphasizes disciplined planning, risk management, and execution, with collaboration across engineering, manufacturing, quality, regulatory, supply chain, and