NPI Program Manager – Medical Device Laser & Production

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

Benefits offered by this job

401k with company match

Onsite health clinics

Cretex University

Paid holidays

Profit sharing

Job summary

Cretex Medical is seeking a Program Manager to drive all aspects of engineering projects from prototyping to production for the Laser Processing unit. You will advocate for the customer, lead cross-functional teams, and ensure compliance with QMS, ISO13485 and FDA standards.

The role involves creating project plans, managing schedules and budgets, coordinating with Engineering, Operations, Supply Chain, and Quality, and guiding transfers to production while pursuing continuous improvement.

Qualifications

• Associates Degree in related field.
• 4 years of experience in contract manufacturing and/or engineering role.
• Extensive experience with medical device contract manufacturing.
• Experience managing numerous projects simultaneously using appropriate software tools (i.e. Excel or Microsoft Project) and professionally communicating project status to customers.
• Understanding of Laser Processing and Assembly.
• Knowledge of ISO 13485, and FDA regulations.
• Complete understanding of MRP and DFM principles.
• Experience with the CAPA system.
• Ability to consistently achieve short and long-term business results.
• Experience with root cause analysis, corrective actions, and preventative action.
• Knowledge and experience with Lean Manufacturing.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint).

Responsibilities

• Administer and manage customer projects through the new product engineering stage gate process to meet requirements, scope, schedule, budget, and quality expectations.
• Ensure compliance to the company Quality Management System (QMS), policies and procedures, regulatory agency standards and guidelines, and customer specifications throughout the development cycle.
• Build and maintain a positive working relationship with internal and external customers.
• Direct and assume responsibility for the actions and performance of the NPI cross-functional team. Facilitate teamwork between departments.
• Create project plans/timelines and promote a sense of urgency to ensure successful commercial launch.
• Understand manufacturing capabilities and capacity of the organization.
• Understand manufacturing and engineering processes that relate to the medical device industry.
• Support estimating efforts for company products and services.
• Lead discussions with customers and internal teams on designs, troubleshooting and finding cost-effective solutions.
• Manage/facilitate transfers to production.
• Communicate with customers on a routine basis and provides project plans, timelines, and milestones.
• Proactively recommends, promotes, and supports actions for implementing continuous improvement projects. Assists internal teams with cost reductions, root cause analysis, and corrective actions.
• 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

Customer communication

MS Excel

MS Project

Lean Manufacturing

Quality Management

MRP/DFM

CAPA

Root cause analysis

Continuous improvement

Microsoft Office

Education

Associates Degree in related field

Bachelor's Degree in Engineering

PMP Certification

Tools

Excel

Microsoft Project

MRP software

Job description

Cretex Medical is seeking a Program Manager to drive all aspects of engineering projects from prototyping to production for the Laser Processing unit. You will advocate for the customer, lead cross-functional teams, and ensure compliance with QMS, ISO13485 and FDA standards.

The role involves creating project plans, managing schedules and budgets, coordinating with Engineering, Operations, Supply Chain, and Quality, and guiding transfers to production while pursuing continuous improvement.