Product Engineer III

Product Engineer III Argon Medical Devices Inc - 3.2 Plano, TX Job Details Full-time 8 hours ago Qualifications Developing medical devices Statistical software Statistics Engineering testing New product development ISO standards Bachelor of Science Engineering Mechanical Engineering Laboratory equipment calibration Supervising experience Bachelor's degree Team management Scientific protocols ASME codes & standards Design controls Regulatory submissions Laboratory staff supervision Quality systems Manufacturing Root cause analysis Senior level Electrical Engineering 4 years Cross-functional collaboration Regulatory compliance management Cross-functional communication FDA regulations Statistical analysis tools Engineering validation

Full 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:

: 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, development, and production of 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.