NPI Program Manager — Medical Device Projects to Production

Cretex Companies, Inc.; Brooklyn Park (MN); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Cretex University

24/7 employee assistance program

Wellness program

Job summary

Cretex Medical is seeking a skilled NPI Program Manager to lead engineering projects from prototyping to production for medical device customers. This indirect leadership role focuses on customer advocacy, cross-functional collaboration, and timely program realization while maintaining quality and regulatory compliance.

You will coordinate with Engineering, Operations, Supply Chain, and Quality to manage scope, timelines, and costs, while ensuring successful audits and on-time delivery.

Qualifications

• Associate degree in related field required.
• 6+ years of experience in medical device assembly design or manufacturing as a project or engineering leader.
• Experience with medical device contract manufacturing.
• Experience managing numerous projects simultaneously using software tools (e.g. Excel or Microsoft Project) and communicating project status to customers.
• Knowledge of ISO 13485 and FDA regulations.
• Proven interpersonal and leadership skills to manage cross-functional teams with accountability to program timelines.
• Facilitate root cause analysis discussions to support problem solving.
• Lean Manufacturing knowledge preferred.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• Ability to work in a manufacturing environment.

Responsibilities

• Manage customer projects to develop and meet requirements, scope, schedule, budget, and quality expectations.
• Build and maintain positive working relationships with internal and external customers that encourages two-way communication.
• Create a sense of urgency and lead customer programs through the organization in a timely manner.
• Facilitate identification of risks to programs during both the Proposal/Quote phase as well as the Program realization phase.
• Work with internal and external customers to put in place risk mitigation strategies and parallel paths as necessary.
• Understand manufacturing capabilities and capacity of the organization.
• Achieve a high-level understanding of manufacturing and engineering processes that relate to the medical device industry.
• Facilitate quotations and proposals for company products and services in a timely fashion that put the business in a position to win new programs.
• Work closely with the manufacturing engineers, quality engineers and operations teams to ensure gross margin targets are maintained or exceeded.
• Lead discussions with customers and internal teams on designs, troubleshooting and finding cost effective solutions.
• Maintain and update project timeliness.
• Manage/facilitate the transfer to production with internal NPD/NPI teams.
• Proactively communicate with customers on a routine basis and provide project plans, timelines, and milestones that meet their expectations.
• Work closely with Engineering, Operations/Production, Supply Chain, Scheduling, and Quality to meet or beat customer delivery dates and On-Time-Delivery (OTD) performance.
• Work with Quality to facilitate customer required audits.
• Supports S&OP planning for assigned programs and customers.

Skills

Project management

Stakeholder communication

Risk management

Excel

Microsoft Project

Cross-functional leadership

Lean Manufacturing

ISO 13485 knowledge

FDA regulations knowledge

Attention to detail

Education

Associate degree in related field

Bachelor’s Degree in Engineering

PMP Certification

Tools

Excel

Microsoft Project

Job description

Cretex Medical is seeking a skilled NPI Program Manager to lead engineering projects from prototyping to production for medical device customers. This indirect leadership role focuses on customer advocacy, cross-functional collaboration, and timely program realization while maintaining quality and regulatory compliance.

You will coordinate with Engineering, Operations, Supply Chain, and Quality to manage scope, timelines, and costs, while ensuring successful audits and on-time delivery.