Product Development Verification Engineer III

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 verification and validation (V&V) strategy and execution for medical device product development. Translates clinical use, design inputs, applicable standards and product risks into verifiable requirements, clinically relevant test methods and defensible evidence. Independently plans and interprets studies, maintains controlled design-control deliverables, and leads implementation of improvements to V&V procedures and practices under Engineering leadership’s guidance and in partnership with cross-functional teams.

What you will do::

• Lead the development and implementation of improvements to V&V procedures, test-method development and validation practices, documentation templates and testing workflows. Identify the need for change, work with Engineering leadership and Quality partners through review and approval and assess the value of the implemented improvement.
• Partner with systems and mechanical design engineers to define verifiable product and system requirements and statistically sound acceptance criteria, including tolerance intervals, confidence levels, sample sizes and design of experiments (DOE), as appropriate.
• Develop and validate test methods and inspection or testing fixtures using applicable ASTM, ASME, ISO and other standards, DOE and engineering best practices; establish methods suitable for design verification and validation.
• Define, review and approve V&V plans, protocols and reports, as authorized, covering product integrity, performance, safety, packaging and shelf life; support usability, biocompatibility, sterilization and software validation, as applicable.
• Partner with Regulatory Affairs on technical content and response strategy for regulatory submissions and agency questions for assigned programs. Develop and review V&V-related evidence, technical rationales, and draft response language grounded in test data, product risk, and clinical-use understanding, while Regulatory Affairs retains ownership of submissions and correspondence.
• Develop clinically relevant benchtop and simulated-use models with Clinical Engineering and Upstream Marketing. Use published literature, available animal and human CT/MRI data, and other technical evidence to define anatomical tortuosity and test conditions; justify how the model represents intended clinical use and imposes representative or justified worst-case stresses on the device.
• Execute verification testing to approved protocols; analyze and document test, results, observations, failures and deviations while maintaining good documentation practices; communicate findings and design-change recommendations to the product development team.
• Work with engineering and cross-functional teams on system integration and validation, functional problems, design trade-offs, product risk mitigation; provide testing evidence and recommendations for design changes.
• Partner with design and systems engineers to draft and review risk-management documentation, including design failure mode and effects analyses (DFMEAs), and connect identified failure modes and design risk controls to verifiable requirements and inspection criteria. Recommend improvements to criteria used in supplier requirements, incoming quality inspections and in-process inspections; support failure and root-cause analysis, statistical engineering rationales and review of the risk-management file; contribute to internal quality-control standards and reliability programs.
• Maintain design-control deliverables, including V&V plans, protocols, reports, data records and the product design-input/output matrix; ensure records and testing procedures comply with applicable standards and Quality System requirements.
• Conduct engineering studies on competitor product and early design concepts, to inform the product development team of their performance
• Independently research technical questions, coordinate cross-functional work and drive assigned V&V activities to completion with minimal supervision.
• Develop an understanding of the scientific, technical, medical, and clinical aspects of company devices and features and the disease states they aim to treat.

Skills for Success::

• 6+ or more years of medical device manufacturing industry experience required. 
• BS Degree or higher in Biomedical, Mechanical, Electrical, Biological, or Physical Science required.
• Strong experience with medical device testing, test method validations (TMV), gauge R&R, and measurement system analysis (MSA)
• Advanced, applied understanding of medical-device design controls and risk-management principles, including the relationship among design inputs, failure modes, design risk controls, verification evidence and inspection criteria.
• Strong knowledge and ability to use industry standards and regulations for medical devices.
• Foundational understanding of standard manufacturing processes.
• Demonstrated experience independently developing and leading a medical-device V&V strategy, including translating design inputs, clinical-use conditions and risks into test plans, methods, acceptance criteria and documented evidence.
• Demonstrated experience leading an implemented improvement to a V&V procedure, test method, documentation practice or testing workflow through cross-functional review and approval. Able to explain why the change was needed, the role personally played in its implementation and the value delivered to the organization.
• Demonstrated experience contributing to DFMEA development or review with design and systems engineers and using risk analysis to improve design inspection criteria or controls that inform supplier requirements, incoming inspection or in-process inspection.

 

Supervisory responsibilities

• Provide technical guidance and mentoring to R&D and cross-functional team members on V&V planning, test methods, execution and interpretation, as assigned.
• May provide technical direction for test-lab activities and support calibration and lab-safety practices within assigned responsibilities.