Senior Product Development Engineer

Argon Medical Devices • Plano, TX

81d

About The Position

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. The Senior Product Development Engineer owns the design change activities of released branded Argon product by working closely with all concerned departments. This position will oversee conformance to manufacturability, optimization, packaging, and documentation with adherence to all applicable standards.

Requirements

• BSME required, MME preferred.
• Minimum 10 years of experience in medical device design required.
• 2+ years of thermoplastic injection/press molding experience required.
• ISO 13485, ISO 14971 and IEC 60601 experience required.
• Root cause analysis, problem-solving skills, and experience with applying statistical techniques such as statistical process control, design of experiments, and problem-solving techniques are required.
• Packaging tool & product design experience required.
• Injection mold and tool design knowledge required.
• Must be willing to travel as needed by project (20% or less).

Nice To Haves

• Exposure to intervention radiology and biopsy product design is preferred.

Responsibilities

• Take ownership of investigating the root cause of high priority problems raised through customer complaint processes and be responsible for ownership of change management for drawings and specifications.
• Work collaboratively with operations to ensure the seamless and successful transition of Sustaining Engineering projects into production.
• Responsible for product design modification, fixtures, instrumentation to support manufacturing.
• Responsible for Design History File and Risk Management file management and updates.
• Work cross-functionally with team members in various departments, including QA, Manufacturing, Procurement, and R&D.
• Generate work instructions for the manufacturing of new products using existing equipment, ensuring adherence to internal quality systems.
• Manage the Project teams.
• Responsible for completing multiple projects on time and within budget.
• Mentor junior engineers.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree