Senior Design Engineer

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

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.