Mechanical Engineer (Medical Devices)

Mechanical EngineerJob Description Position Overview: Phillips-Medisize, India is seeking a Senior Mechanical Design Engineer to design and develop medical device and drug delivery products, following the Phillips-Medisize Design Development Process (DDP) and applicable standards such as ISO 13485 with design controls, ISO 14971 and appropriate ASME standards. Essential FunctionsOperate primary CAD systems such as NX or SolidWorks or CreoGenerate product designs that meet product requirementsIdentify and analyze design risks using tools such as tolerance analysis, static or dynamic simulation or hand calculations.Develop appropriate design risk mitigations and test strategiesWork with production facilities to understand and incorporate production intent design for manufacturing (component level) and design for assembly (assembly level) into the design.Develop appropriate assembly and test fixtures to aid in the manufacture and testing of the design,Integrate the electronic elements into the product designDevelop appropriate drawings to detail product and assembly specifications in a manner compliant with ASME or other design standardsMaintain a design journal that identifies product risk and tracks design changes throughout the Design Development Process.Generate Database Approval Forms and Engineering Change Orders to document design changes and customer approval.Identify and assess Design Risk via a dFMEAIdentify potential manufacturing risks within the design of the components and assembly.Use or coordinate appropriate analytical techniques such as Tolerance Analysis, MoldFlow, SWX Simulation, SWX Plastics or ANSYS to aide in the analysis of the designEnsure that design inputs and outputs are properly documented and controlled according to relevant procedures.Generate and control Drawings and Specifications according to relevant work instructions.Set up and Perform engineering test for component verification against mechanical specification.Design/selection of components used in drug delivery devices such as springs, elastomers, plastic parts, sheet metal components, Selection of material for plastic parts, elastomers that encounters drugs.Design of parts compliance to US pharmacopeia standards such as USP 87, US 88, USP 661, USP 381, ISO 10993.Generate free body diagrams considering intended use cases and unintended use cases.Design of mechanism with appropriate number of constraints. Perform kinematic evaluation of mechanism.Identify functions in a product that are essential to performance.Generate engineering test data and use statistical tools to analyze engineering test data.Determining safety factors for each mechanical specification considering uncertainty in loading conditions, material property variations, environmental factors, material ageing.Other duties as assigned. Qualifications Required Qualifications:Bachelor of Science in Mechanical Design or EngineeringMinimum 7 years of experience in the design of mechanical or electro-mechanical drug / biologic delivery devices (pen injectors, auto-injectors and wearable pumps).Plastic injection molding and product developmentDesign experience with medical devices or similar productsStrong Design for Manufacturability experience focusing on plastic injection molding and plastic assembly methods (snaps, sonic welding, press fit, sealing, etc)Proven history of providing innovative design solutionsExperience performing tolerance analysis and structural analysisDiverse product portfolio Skills And AbilitiesFamiliar with ISO 13485 and ISO 14971Ability to generate complex solid modelsFamiliar with various plastic materials and design limitations or potential design risks for said materialUse of Minitab for statistical calculation and engineering decision makingUse of strength analysis toolsStrong written and verbal communication skills; ability to communicate design intent to a diverse audienceExperienced understanding of injection mold operationUnderstanding of the behavior of plastics and other materials as they relate to mechanics, function, and creepDemonstrates strong ability to evaluate and recommend appropriate prototyping processes (i.e. SLA, printed, machined, molded)Maintains and respects customer, project, and program confidentialityMotivated self-starter who is able to manage multiple tasksWe offer youA challenging position in an international innovative and successful company that is growing.An opportunity to setup the processes and development team in India to support the Indian customers. An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India.Well-structured training and continuous development of your competencies. Exciting career possibilities within the constantly growing area of medical devicesSalary on a competitive level.The Company - In Short Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region. PRB