Product Engineer III

Argon Medical Devices, Inc.; Plano (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

Argon Medical Devices, Inc. in Plano, Texas is seeking a skilled professional to lead the development of medical devices. The role encompasses engineering studies on product performance and collaboration with cross-functional teams to ensure compliance with industry standards. Candidates should possess a BS degree in a relevant field, have a minimum of 4 years in the medical device industry, and demonstrated knowledge of design controls and testing methodologies. The position may involve supervising test lab activities and offers an opportunity to impact patient outcomes through innovative device design.

Qualifications

• 4 or more years of medical device industry experience.
• Strong experience with medical device testing and validations.
• Ability to design, develop, and produce fixtures for inspection.

Responsibilities

• Lead development of medical devices ensuring design input requirements.
• Develop data through engineering studies on product performance.
• Ensure compliance with the product development process and quality requirements.

Skills

Medical device industry experience

Knowledge of industry standards

Statistical analysis software

Design controls per FDA requirements

Time management

Education

BS Degree or higher in Biomedical, Mechanical, Electrical, Biological, or Physical Science

Tools

Statistical analysis software

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‑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.

Position Overview

Leads and participates in the development of medical devices by leveraging knowledge of industry standards/test methods, clinical use, the product development process and design controls to ensure design input requirements are verifiable and by management of design verification and validation activities.

What you will do

• Develop data through engineering studies that informs new product development team about performance of the product and competitors.
• Partner with systems and mechanical design engineers in defining product requirements such that they are verifiable.
• Leverage regulatory standards from ASTM, ASME, ISO, etc., Engineering DOEs, and general industry best practices for developing Test Methods.
• Support the mechanical design engineers to solve problems and utilize engineering best practices and techniques for root cause (failure analysis) and statistical analysis (engineering rationales).
• Develop Design Verification Plans, Protocols & Reports. Conduct preclinical design verification and design iteration assessments of products.
• Support technical discussions for projects including system design trade-offs, product risk mitigation, technical problem and responses for regulatory submission.
• Support Clinical engineering and Up-Stream marketing to develop clinically relevant simulative use bench top models.
• Ensure compliance to the product development process and Quality System and Design Control requirements.
• Support mechanical design and cross‑functional team members through the review of risk management file to mitigate the product risk.
• Develop understanding of the scientific, technical, medical, and clinical aspects of company devices and features and the disease states they aim to treat.
• Execute testing per protocols and record and communicate the test results, observations, failure modes, and deviations clearly to cross‑functional team members.

Skills for Success

• BS Degree or higher in Biomedical, Mechanical, Electrical, Biological, or Physical Science required.
• 4 or more years of medical device industry experience.
• Strong knowledge and ability to use industry standards and regulations for medical devices.
• Foundational understanding of standard manufacturing processes.
• Strong understanding of design controls per FDA and MDD/MDR requirements.
• Strong experience with medical device testing, test method validations (TMV), gauge R&R, and measurement system analysis (MSA)
• Ability to design, develop, and produce fixtures for inspection and testing.
• Demonstration of time management to complete tasks on schedule and vertical communication promptly to ensure transparency.
• Use of statistical analysis software and strong fundamental understanding of engineering statistics for the medical device industry.
• Travel 5-10%

Supervisory Responsibilities

• May supervise activities within the test lab and manage calibration and safety of the lab environment.
• May provide guidance to other R&D team members and cross‑functional team members.