Principal Engineer, Mechanical

Role Overview

• 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