Senior NPI Project Manager, Medical Devices

Acumed LLC; Hillsboro (OR); On-site; USD 110,000 - 160,000; Full time

Job summary

Acumed LLC is seeking a Senior Project Manager to independently plan, lead, and execute multiple complex NPI projects, guiding cross-functional Product Development Teams from initiation to launch.

The role emphasizes scope, schedule, cost, quality, and risk management, collaboration with Program and Product Management, FDA/ISO compliance, and mentoring other project managers; office in Hillsboro, OR.

Qualifications

• NPI project management experience in an engineering/manufacturing environment producing regulated durable goods such as medical devices, high technology, or defense.
• Experience leading complex cross‑functional projects and working with internal/external stakeholders and customers.
• Knowledge of FDA and ISO regulations and proven leadership, communication, problem‑solving, and stakeholder management.

Responsibilities

• Lead 3-7 large, complex NPI projects simultaneously from initiation through implementation.
• Establish project objectives, scope, schedules, budgets, resources, and deliverables; manage scope changes throughout the project lifecycle.
• Lead cross-functional Product Development Teams and coordinate with functional leaders to ensure appropriate resources and expertise.
• Drive project risk management, validation and verification activities, design reviews, technical problem solving, and corrective actions.
• Ensure project documentation and Design History Files (DHF) are complete and maintained in accordance with FDA and quality requirements.
• Facilitate customer preference, design review, and product validation labs.
• Monitor project performance and develop recovery plans when projects fall behind scope, schedule, budget, or quality objectives.
• Communicate project status, risks, and priorities to executives, sponsors, and key stakeholders.
• Partner with Program Management and Product Management on product roadmaps and process improvements.
• Mentor and provide guidance to other Project Managers.
• Support project management, change management, ERP/SAP, and PLM processes and training.

Skills

NPI project management

FDA/ISO regulations

MS Project

ERP/SAP experience

Leadership & mentoring

Education

Bachelor’s in Engineering or related field

MS/MBA and PMP preferred

Tools

MS Project

SAP/ERP

Job description

Acumed LLC is seeking a Senior Project Manager to independently plan, lead, and execute multiple complex NPI projects, guiding cross-functional Product Development Teams from initiation to launch.

The role emphasizes scope, schedule, cost, quality, and risk management, collaboration with Program and Product Management, FDA/ISO compliance, and mentoring other project managers; office in Hillsboro, OR.