Applies scientific principles to generate new concepts and demonstrate proof of principle via design analysis and prototypes for the new medical devices design and various complex problems
Apply medical device Design Control procedures to successfully develop concepts into products and provide engineering deliverables for all phases (concept, definition, development, qualification and launch) of the Product Development Process (PDP)
Design products used for infusion of fluids and medication, focused on disposable, sterile products used in infusion pumping systems
Perform engineering analysis utilizing tools such as MatLab, and ANSYS Finite Element Analysis (FEA) to assess feasibility and robustness of design
Must be proficient in selection of medical device engineering materials, plastic and metal components design, geometric dimensioning and tolerance analysis (GD&T), critical to function (CTF) and tolerance stack-up analysis
Expertise in medical device risk analysis and Failure Mode Effects and Criticality Analysis (FMECA) as per ISO 14971:2019 regulations, Design for Manufacturability (DFM) and Design for Testability (DFT)
Must be familiar with Lean Management methodology
Develop test methods and fixtures for medical device verification and Validation
Apply analytical and statistical methodologies to support design decisions
Provide technical leadership to internal and external partners for product development and on-market product support
Propose original and innovative technologies and provide input to the legal department when preparing patent applications
Coordinate the activities of designers and technicians to meet overall project objectives
Assess the various technical and schedule risks and define appropriate contingency plans
Communicate up and down the organization with status updates and any technical issues or issues relating to the balance between scope, resource and schedule
Coordinates with third party development partners, specifies project deliverables, and reviews work output
Understands medical regulations and standards and the applicability to product performance and testing requirements
Work on special projects as they arise, including root cause, NCR and CAPA investigations, customer complaints analysis, remediation activities and other ongoing product sustaining work
All other duties as assigned
Requirements
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or closely related field (or foreign equivalent)
Ten (10) years of experience in the job offered or closely related occupation
Experience in Medical device design and development from concept generation through product launch
Knowledgeable in FDA, EU MDR medical device regulations & design controls
Proficient in design of components, assemblies, and drawings utilizing SolidWorks
Proficient in development of engineering drawings, including application of Geometric Dimensioning and Tolerancing (GD&T)
Proficient in selection of engineering materials to meet technical product requirements
Knowledgeable in the application of statistical analysis including capability studies, t-tests, minimum required sample size, and other similar analysis
Proficient in tolerance stack-up analysis of mechanical assemblies
Knowledgeable in the design of multi cavity plastics moldings and advanced medical device manufacturing techniques
Experience using file configuration management (PDM) and Product Lifecycle Management (PLM) systems
Knowledgeable in application of Finite element analysis (FEA)
Benefits
May work from home from anywhere within the US
< 5% domestic and international travel required per year