Thrombectomy Product Development Engineer Lead Job at Argon Medical Devices Inc, Plano, TX

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  • Argon Medical Devices Inc
  • Plano, TX

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 Thrombectomy Product Development Engineer Lead serves as the senior technical authority for Argon’s Thrombectomy Management System. This role provides hands-on engineering leadership for a complex, released medical device platform with primary accountability for system-level performance, reliability, safety, and compliance in both field use and production.

This is not a people management or program coordination role . It is a senior individual contributor position requiring deep technical expertise, strong engineering judgment, and end-to-end ownership of sustaining, defending, and continuously improving a flagship medical device system. The role translates real‑world field feedback, quality signals, and manufacturing insights into robust engineering solutions and technical decisions.

What you will do::
  • Maintain deep technical understanding of the Thrombectomy Management System across design, clinical use, manufacturing, and field performance
  • Act as the system-level technical owner for product performance, user experience, and failure modes
  • Lead engineering execution of design changes (DCRs) driven by field issues, internal quality findings, regulatory needs, and performance gaps
  • Own technical decision-making for product reliability, safety, compliance, and manufacturability
  • Prioritize and resolve a dynamic backlog of sustaining engineering issues from field, quality, operations, and commercial teams
  • Lead root cause investigations and structured troubleshooting of complex electromechanical, fluidic, and software-integrated systems
  • Partner closely with Quality and Operations to investigate and resolve internal product and manufacturing issues
  • Collaborate with Regulatory Affairs to support domestic and international submissions, ensuring engineering changes meet applicable regulatory and standards requirements
  • Translate investigation outcomes into clear design requirements, specifications, corrective and preventative actions
  • Ensure verification and validation activities adequately address real‑world use, manufacturing variability, and field risk
  • Drive issues to closure with strong technical rigor, documentation, and accountability
  • 10% travel required
Skills for Success::
  • Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related discipline)
  • Minimum of 15 years of experience in medical device development, product engineering, or system engineering
  • Demonstrated experience supporting, sustaining, and improving complex commercialized medical device systems
  • Proven track record resolving complex field and internal product issues and driving design changes in released products
  • Strong working knowledge of applicable regulatory requirements and standards (e.g., IEC 60601, ISO 14971)
  • Experience with risk management, verification and validation, complaint investigations, and design control processes
  • Exceptional hands-on technical depth and problem-solving skills

Preferred Education and Experience

  • Master’s degree or PhD in Engineering or related technical field
  • Prior experience serving as a system or technical lead for a flagship or platform-level medical device
  • Experience supporting global regulatory submissions and sustaining engineering for international markets

Job Tags

Full time

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