Sr. Project Manager, CPS

Argon Medical 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.

Excellent opportunity for a Sr. Project Manager, CPS to join our team in Wheeling, IL!

What you will do:

The Project Manager will manage projects related to the development, implementation and sustaining of Custom Product Solutions (CPS/OEM) products and services for Argon Medical Devices, interact with CPS customers, and effectively manage and communicate project progress to management.

• Responsible for the development and execution of semi-complex project/program plan.
• Performs project/program management activities such as planning, scheduling, budgeting, risk management, change management, opportunity, and resource management.
• Performs technical review of product/process design and documentation.
• Assist with quoting new products/projects.
• Perform active role in maintaining customer relationship.
• Provide engineering support for the development and manufacturing of new products. Evaluate proposed designs for manufacturability.
• Develop drawings or models for new or existing products or fixtures.
• Support process validation activities such as IQ/OQ/PQ.
• Provide technical information concerning manufacturing or processing techniques, materials, properties, and process advantages and limitations to internal or external stakeholders for review or planning.
• Compare product or equipment specifications with new product design and performance requirements to determine if new products can be produced by existing manufacturing methods.
• Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality and reliability.
• Confer with planning and design staff concerning product design and tooling to ensure efficient production methods.
• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or parts and evaluate products according to specifications and quality standards.
• Estimate production times, staffing requirements, and related costs to provide information for management decisions.
• Confer with management, engineering, and other staff regarding production capabilities, production schedules, and other considerations to facilitate production processes.
• Develop, implement, train, and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations
• Lead functional and cross-functional teams to achieve project goals.
• Mentor junior engineers in project management activities

Skills for Success:

• Bachelor’s Degree or higher in Biomedical, Mechanical, Industrial, or other engineering.
• Minimum of five (5) years related experience in FDA/GMP regulated industry.
• Proficient in AutoCAD, SolidWorks, Minitab, Word, Excel and MS 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/PQ)
• Some travel to vendors, customers, and conferences - <10%

Argon Medical is an equal opportunity employer and complies with anti-discrimination laws. We believe that inclusion and diversity fosters creativity, innovation, and empowers all our employees which makes us a stronger organization overall. We promote a culture that maintains a balanced and diverse workforce.