Senior Design Engineer

Job Description Summary

The Senior Engineer will be involved with all aspects of design engineering including new product design and optimizing existing products. In doing so the Senior Engineer will follow BDs Global Product Development System and relevant engineering tools to deliver a high quality, cost-effective design using BD's Stage Gate framework, DFM/DFSS to deliver cost-effective design-transfer and see it through into manufacturing. The associate will also be responsible for supporting the verification strategy creation and execution to deliver high-volume medical products. The associate will also support test method development activities encompassing measurement system development & analysis, test fixture design and equipment hardware/software validation for measurement system equipment. He/she will ensure that translated product requirements are testable and measurable. The ideal candidate will also participate in executing technical and multi-functional design verification and design validation activities

Job Description

• DriveR&Deffortsthroughallphasesofproductdevelopment.
• Translatecustomerandoperationalrequirementsintoverifiableproductrequirementsand specifications.
• Drivedesignoptimizationattheintersectionofmaterial,formfactor,process,andhumanfactors considerations.
• Criticallyevaluateandanalysesystemperformanceandreliability.
• ImplementDFSSrigorthroughoutthedesignselectionanddevelopmentprocess.
• EvaluatedesignconsiderationstooptimizerelevantDFX(DesignforExcellence)criteria.
• Participateindesigneffortsoverthecontinuumofproductdevelopmentand/orlifecycle management/ Sustenance engineering.
• Coordinatewiththecross-functionalteams(i.e.,D&D,SystemsEngineering,Marketing,Quality, Regulatory, Manufacturing Technology, Operations etc.) to deliver the design solutions.
• Developtechnicaldesignand/orverificationdocumentations,draftengineeringandtestplans, drawings, 3D models as needed.
• FollowDesignControl&ensurecompliancewithalllocal,state,federal,international,and internal safety regulations, policies, and procedures.
• Define,planandleadactivitiesfortestmethod&measurementsystemdevelopmentand validation and testing optimization in support of Design Verification.
• Leadcreationandexecutionofverificationprotocols,summarizeresults,enableformal design reviews, and own the verification portion of the Design History File.
• DemonstrateproficiencyinspottingDesignVariancethroughrelevantstatisticalmeasures.
• Interpretandanalysedesignverificationdatawithrespecttoproductperformanceand operational stability in the manufacturing plants.
• Applicationofengineeringfirstprinciplesandadvancedengineeringmethodstogaindeep understanding of the underlying technical issues, and to propose and implement robust solutions.
• Synthesize, develop, update, and optimize designs based on understanding design space.Understanddesignoptionsandtrade-offs;managingcriticalparameters;leverage strong engineering fundamentals and tools. Incorporate manufacturing principles early in the development process.
• ExecutesContinuousImprovementprojectsinthefollowing(butnotlimitedto)areas.
• Equipmentormethodtroubleshooting/repairs.
• CoordinateswithTestMethodDevelopmentandVerification&Validationteamforequipmentand method validations
• MethodorEquipmentUpgrades
• Fixturemaintenance
• DrawingorSpecificationmodifications
• ResponsibleforCompleteendtoendmaintenanceoftestequipmentandmanagementof Test method validation records.
• Ensuredeliverablesarereliableacrossthedesignspace,isadequatelypressure-testedto satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
• Implement DFSS rigor throughout the design selection and development process, leveraginganddeployingempirical,statistical,andanalyticaltoolstodriveinformed design decisions and reduce design iteration cycle times.
• Optimizeproductdesign,materialselection,productfeatures,processdesignandhuman-factor need based on the project needs.
• Analyzethedesignandutilizerobustengineeringprinciplestoensurethatthedesignisoptimized to satisfy product and business requirements.
• Shouldbeabletoworkondrawings,modelingusingCAD packages.
• EnsurethedesignconsiderationsareembeddingallapplicableDFX(DesignforExcellence) aspects including manufacturability, serviceability, reliability, and safety.
• Createanddocumentnoveltestmethodologiesandprovidefeedbackand recommendations for product/design changes.
• Activelybuildonpersonalskills,expertise,andcompetencies.Ensurethattechnical lessons are reviewed, learned, and disseminated.
• Coachandmentorjuniorengineersandtechnicianstoexecuteprojectdeliverables.
• EnsurecompliancewithBDqualitypolicies,procedures,andpractices.
• TheincumbentwillalsoberesponsibleforensuringQMSconformanceandensurethat the quality policy and objectives are met per organizational guidelines.

• Minimumbachelor'sinmechanical,Materials,orBiomedicalEngineeringoracloselyrelated technical field. Advanced degree preferred.

• Minimum 6-10 years of experience leading / supporting product development projects in medical device, pharma, or related industries.
• Provenhands-onexperiencewithDesignandDevelopmentofhigh-volumeproducts.
• Experienceorunderstandingofimplementingproductchangesthroughastructured,phase-gated, product development process.

• Experience and expertise in Value Analysis Value Engineering (VAVE) processandmethodologies,LeanEngineering,LeanProductDevelopment methodologies and approaches.
• Experienceleading/supportingproductdevelopmentprojectsinmedical. device, pharma, or related industries.
• Goodunderstandingofmedicaldeviceproductdevelopmentrisk management methodologies (EURA, FMEA, etc.).
• Experienceinproductinnovationrelatedtocost-savingsisgreattohave.

• Stronginterpersonalandinfluenceskills.
• Strongwrittenandverbalcommunicationskills.
• Advanced Critical thinking skills.
• Strong Cross functional Project Leadership skills.
• Strong technical and managerial judgment.
• Teamorientation.
• Strongskillsinprojectplanningandmanagement.
• Broadanddeepunderstandingofdisciplinedchangecontrolprocesses, regulatory and quality requirements.
• Strongmotivationalfit.
• StrongfitwithBDvalues.