NPI Program Manager — Medical Device Programs

Cretex Medical Component and Device Technologies; Brooklyn Park (MN); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

401k with match

Onsite health clinics

Cretex University

Discretionary holiday bonus

Job summary

Cretex Medical is seeking an NPI Program Manager to guide engineering projects from prototyping through production, acting as the customer advocate and coordinating cross-functional teams in a regulated medical device environment.

You will manage scope, schedule, budget, and quality, mitigate risks, and collaborate with Manufacturing, Quality, and Supply Chain to ensure on-time delivery and successful transfer to production.

Qualifications

• Associate degree in related field.
• 6+ years in medical device assembly design or manufacturing as a project or engineering leader.
• Extensive experience with medical device contract manufacturing.
• Experience managing numerous projects simultaneously using software tools like 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.
• Demonstrated ability to achieve short and long-term business results.
• Facilitate root cause analysis discussions to identify underlying issues and promote collaborative problem-solving.
• Knowledge and experience with Lean Manufacturing preferred.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• Strong attention to detail.
• 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 relationships with internal and external customers.
• Create a sense of urgency and lead customer programs through the organization.
• Facilitate identification of risks to programs during Proposal/Quote and Program realization phases.
• Work with customers to implement risk mitigation strategies and parallel paths as needed.
• Understand manufacturing capabilities and capacity of the organization.
• Achieve a high-level understanding of manufacturing/engineering processes related to medical devices.
• Facilitate quotations and proposals for company products and services to win new programs.
• Collaborate with manufacturing, quality, and operations to maintain or exceed gross margin targets.
• Lead discussions on designs, troubleshooting, and cost-effective solutions.
• Maintain and update project timeliness.
• Manage transfer to production with NPD/NPI teams.
• Proactively communicate with customers with plans, timelines, milestones.

Skills

Project management

Cross-functional leadership

ISO 13485 & FDA knowledge

Lean manufacturing

Communication

Manufacturing environment

Education

Associate degree in related field

Bachelor’s Degree in Engineering

PMP Certification

Tools

Microsoft Project

Excel

PowerPoint

Outlook

Job description

Cretex Medical is seeking an NPI Program Manager to guide engineering projects from prototyping through production, acting as the customer advocate and coordinating cross-functional teams in a regulated medical device environment.

You will manage scope, schedule, budget, and quality, mitigate risks, and collaborate with Manufacturing, Quality, and Supply Chain to ensure on-time delivery and successful transfer to production.