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 Senior Manufacturing Engineer at our manufacturing facility in Athens, TX!

Location: Athens, TX is 1 hour and 20 minutes southeast of downtown Dallas. It's a rural, peaceful area but a short drive to Dallas or Tyler, TX.

What you will do:

This role will drive the design and development of manufacturing processes, equipment, and documentation to successfully introduce new products into manufacturing for Argon Medical Devices. Effectively manage and communicate project progress to management.

• Provide manufacturing engineering support for the development and manufacturing of new products
• Evaluate proposed designs for manufacturability and provide DFM recommendations
• Develop and establish robust and repeatable processes and perform process validations (IQ/OQ/PQ)
• Represent manufacturing engineering in cross-functional teams
• Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis
• Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality
• Provides technical supplier management support as related to product development and introduction 
• Analyze and plan work force utilization, space requirements, and workflow and designs layout of equipment and workspace for maximum efficiency.
• 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
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations

Skills for Success:

• Bachelor’s (or advanced) degree in biomedical, mechanical, industrial or similar engineering discipline
• 8 years related experience in FDA/GMP regulated industry.
• Proficient in SolidWorks, Minitab, Word, Excel and Project
• Experience in product development and manufacturing methods, procedures, and cost reduction/yield improvement techniques
• Background in medical device assembly, automation, and vision system technology
• Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required
• Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)
• Ability and willingness to work within a collaborative team environment.
• Must be a proactive self-starter who enjoys challenges and variety.
• Excellent verbal and written communication skills.
• Proven record of delivering multi-disciplinary projects on time and on budget.
• Ability to perform and manage a wide range of activities in a high paced results-oriented environment.

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.