Medical Device Program Manager — NPI & Production Launch

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

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus

Job summary

Cretex Medical in Minnesota seeks a Program Manager to support the Laser Processing unit, guiding customer programs from prototyping to production while ensuring quality, schedule, and cost targets.

You will lead an NPI cross-functional team, coordinate with engineering, operations, supply chain and quality, and drive continuous improvement through CAPA actions and regulatory compliance with ISO 13485 and FDA requirements.

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 with Excel or Microsoft Project and 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.
• MS 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 advocacy

Cross-functional leadership

Communication

Regulatory knowledge

MRP & DFM

CAPA system

Lean Manufacturing

MS Office proficiency

Quality systems understanding

Root cause analysis

Education

Associates Degree in related field

Bachelor’s Degree in Engineering

Tools

Excel

Microsoft Project

MS Office

Job description

Cretex Medical in Minnesota seeks a Program Manager to support the Laser Processing unit, guiding customer programs from prototyping to production while ensuring quality, schedule, and cost targets.

You will lead an NPI cross-functional team, coordinate with engineering, operations, supply chain and quality, and drive continuous improvement through CAPA actions and regulatory compliance with ISO 13485 and FDA requirements.