QE NPD

Description

• Design and develop medical instruments (disposable and reusable), catheters, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.
• Generate innovative concepts for new medical device designs to satisfy clinical requirements. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.
• Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to personnel and to the project's client company.
• Utilize SolidWorks to develop detailed 3-D CAD models and drawings of medical instruments (disposable and reusable), catheters, implants, and/or packaging. Includes component, subassembly, and top-level drawings.
• Interact with client companies in a professional manner.
• Maintain Design History Files (DHFs) per company procedure. Ensure that DHFs are accurate, complete and well organized.
• Conduct risk analysis for products under development. Conduct and document Failure Mode and Effects Analysis per company procedure.
• Perform tolerance analysis of components and assemblies to ensure proper fit and function.
• Produce prototype devices for testing, and for evaluation by client companies. Work with internal and/or external resources to produce prototype device components. Assemble and/or evaluate prototype devices.
• Conduct product verification and validation testing to demonstrate product safety and efficacy. Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test results. Write test reports which draw conclusions from the results.
• Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
• Conduct Design Reviews as specified in project plans, and in accordance with company procedure.
• Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Participate in Material Review Board activities. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.
• Date, sign and have witnessed all documents that may establish inventorship dates.

• Bachelor's degree in Mechanical or Biomedical Engineering is required. Master's degree in Engineering, Management or Business is desired.
• Minimum of 5 years of medical device product design and development experience is required.
• Demonstrated ability to bring products from concept to market.
• SolidWorks 3D CAD proficiency.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• Knowledge of probability and statistics.
• Depth of knowledge in one or more clinical areas; interventional cardiology is desired.
• Depth of knowledge in one or more product areas; catheters is desired.
• Depth of knowledge in one or more technical areas, for example finite element analysis.
• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
• Any equivalent combination of education and experience, which provides the applicant with the knowledge, skills, and abilities required to perform the job, will be considered.