Thrombectomy Product Development Engineer Lead

Argon Medical Devices Inc • Plano, TX

1d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees