Project Manager

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Job description

Company Overview
Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon's brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview
The Project Manager, CPS (Custom Product Solutions) will manage projects related to the development, implementation and sustaining of CPS products and services for Argon Medical Devices, while interacting with CPS customers and effectively managing and communicating project progress to management.

What you will do
Responsible for the Development and execution of semi-complex project/program plan.

Performs project/program management activities such as defining, scheduling, budgeting, risk management, change management, opportunity, and resource management.

Performs technical review of product/process design and documentation.

Assists with quoting new products/projects.

Performs active role in maintaining excellent customer relationship.

Provides engineering support for the development and manufacturing of new products. Evaluates proposed designs for manufacturability.

Creates drawings or models for new and existing products or fixtures.

Lead/supports process validation activities such as IQ/OQ/PQ.

Provides technical information concerning manufacturing or processing techniques, materials, properties, and process advantages and limitations to internal or external stakeholders for review or planning.

Compares product or equipment specifications with new product design and performance requirements to determine if new products can be produced by existing manufacturing methods.

Performs root cause analysis of product/process issues and implements short and long-term corrective actions to improve product quality and reliability.

Confers with planning and design staff concerning product design and tooling to ensure efficient production methods.

Confers with vendors to determine product specifications and arranges for purchase of equipment, materials or parts and evaluates products according to specifications and quality standards.

Estimates production times, staffing requirements, and related costs to provide information for management decisions.

Confers with management, engineering, and other staff regarding production capabilities, production schedules and other considerations to facilitate production processes.

Develops, implements, trains and monitors effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations.

Other duties as assigned.

Skills for Success
Bachelor's Degree or higher in Biomedical, Mechanical, Industrial, or other engineering discipline required. Masters degree preferred.

Minimum of five (5) years related experience in FDA/GMP regulated industry.

Proficient in AutoCAD, SolidWorks, Minitab, Word, excel and Project.

Working knowledge of manufacturing methods, procedures, and cost reduction/yield improvement techniques.

Experience with design, review, execution, and approval of installation, Operation and Process Qualification protocols and reports (IQ/OQ/PO).

Some travel to Argon manufacturing sites, vendors, customers, and conferences -

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