Senior NPI Project Leader – Medical Devices

Marmon Holdings, Inc.; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Acumed LLC in the United States is seeking a Senior Project Manager to independently plan, manage, and execute multiple complex NPI projects, leading cross-functional Product Development Teams from initiation through implementation.

You will ensure scope, schedule, cost, quality, and risk objectives are met, partner with program and product management on roadmaps, and mentor other project managers while maintaining FDA/ISO compliance.

Qualifications

• Bachelor’s degree in Engineering or related field; 8–10 years experience; MS/MBA and PMP preferred.
• 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.
• Experience in a formal gated product development/project management environment.
• Knowledge of FDA and ISO regulations.
• Demonstrated leadership, communication, problem-solving, stakeholder management, and mentoring skills.
• High proficiency with MS Project or equivalent project management software required.
• Experience with project management and product development tools, including design reviews, root cause analysis, work breakdown structures, and corrective action methods.
• SAP or other ERP experience preferred.
• Familiarity with medical device or similar regulated product development environments.
• General understanding of financial analysis, market research, pricing, and product launches.

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

Cross-functional leadership

MS Project

Problem-solving

Communication

Stakeholder management

Mentoring

Project management

Gated development processes

Education

Bachelor’s degree in Engineering or related field

MS/MBA and PMP preferred

Tools

MS Project

SAP

ERP systems

Job description

Acumed LLC in the United States is seeking a Senior Project Manager to independently plan, manage, and execute multiple complex NPI projects, leading cross-functional Product Development Teams from initiation through implementation.

You will ensure scope, schedule, cost, quality, and risk objectives are met, partner with program and product management on roadmaps, and mentor other project managers while maintaining FDA/ISO compliance.