Senior NPI Project Lead for Regulated Devices

Acumed-ffe1f67; Hillsboro (OR); On-site; USD 130,000 - 170,000; Full time

Job summary

Acumed LLC in Hillsboro, Oregon seeks a Senior Project Manager to independently plan, manage, and execute multiple complex NPI projects, leading cross-functional Product Development Teams from initiation to implementation.

You will set objectives, scopes, schedules, budgets, and resources, drive risk management, validations, design reviews, and ensure DHF compliance with FDA/ISO requirements, while guiding stakeholders and mentoring junior PMs.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 8–10 years NPI project management in regulated environment.
• PMP or equivalent certification preferred.

Responsibilities

• Lead 3–7 large, complex NPI projects from initiation through implementation.
• Establish objectives, scope, schedules, budgets, resources, and deliverables.
• Manage risk, design reviews, RCA, and corrective actions.
• Maintain DHF in line with FDA/ISO requirements.
• Communicate status and risks to executives and stakeholders.
• Mentor other Project Managers and support PM processes.

Skills

Leadership

Cross-functional coordination

Project risk management

Stakeholder management

Mentoring

Communication

Problem-solving

FDA/ISO knowledge

MS Project

Education

Bachelor’s degree in Engineering or related field

MS/MBA preferred

PMP certification preferred

Tools

MS Project

SAP

ERP systems

PLM software

Job description

Acumed LLC in Hillsboro, Oregon seeks a Senior Project Manager to independently plan, manage, and execute multiple complex NPI projects, leading cross-functional Product Development Teams from initiation to implementation.

You will set objectives, scopes, schedules, budgets, and resources, drive risk management, validations, design reviews, and ensure DHF compliance with FDA/ISO requirements, while guiding stakeholders and mentoring junior PMs.