Senior Engineer

Job Description SummaryJob DescriptionP3-114391. About BDBD is one of the largest global medical technology companies in the world and is advancingthe world of health by improving medical discovery, diagnostics, and the delivery of care. Thecompany develops innovative technology, services and solutions that help advance both clinicaltherapy for patients and clinical process for health care providers. BD has 70,000 employeesand a presence in virtually every country around the world to address some of the mostchallenging global health issues.2. About BD TCI"BD, a 125-year-old global medical device company has started its Enterprise Center inBangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be anintegral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory,IT and other functions. The center boasts of some of the brightest minds who work in a uniqueenvironment that fosters and supports ingenuity. BD TCI is dedicated to serving BD's customersand patients thereby contributing its bit towards "advancing the world of health".3. Position SummaryThe right candidate will be placed in the Product development or Product engineering team.The Senior Engineer will be involved with all aspects of design engineering including newproduct design and optimizing existing products. In doing so the Senior Engineer will follow BDsGlobal 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-effectivedesign-transfer and see it through into manufacturing. The associate will also be responsiblefor supporting the verification strategy creation and execution to deliver high-volume medicalproducts. The successful candidate will also support test method development activitiesencompassing measurement system development & analyses, test fixture design andequipment hardware/software validation for measurement system equipment. He/she willensure that translated product requirements are testable and measurable. The ideal candidatewill also participate in executing technical and multi-functional design verification and designvalidation activities4. Educational BackgroundFull time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial &Production, Chemical, Materials Engineering) or Master Degree in a relevant engineering fieldis an added advantage.5. Professional Experience 5 to 8 years of experience in medical device or other regulated industry supporting productdevelopment/ sustenance engineering projects Exposure to six sigma and lean methodologies would be an advantage. Candidate should have good CAD & PLM Exposure. Candidates with prior experience in Medical Devices will be preferred.6. Job Responsibilities Drive R&D efforts through all phases of product development . Have Strong CAD background(Component , Subassembly , Skeleton Model , Relations , CAD Standards , GD&T ) Translate customer and operational requirements into verifiable product requirements andspecifications Drive design optimization at the intersection of material, form factor, process, and humanfactors considerations Critically evaluate and analyse system performance and reliability Implement DFSS rigor throughout the design selection and development process Evaluate design considerations to optimize relevant DFX (Design for Excellence) criteria. Participate in design efforts over the continuum of product development and/ or life cyclemanagement/ Sustenance engineering. Coordinate with the cross-functional teams (i.e., D&D, Systems Engineering, Marketing,Quality, Regulatory, Manufacturing Technology, Operations etc.) to deliver the designsolutions. Develop technical design and/ or verification documentations, draft engineering and testplans, drawings, 3D models as needed. Follow Design Control & ensure compliance with all local, state, federal, international, andinternal safety regulations, policies, and procedures. Define, plan and lead activities for test method & measurement system development andvalidation, and testing optimization in support of Design Verification. Lead creation and execution of verification protocols, summarize results, enable formaldesign reviews and own the verification portion of the Design History File. Demonstrate proficiency in spotting Design Variance through relevant statistical measures Interpret and analyse design verification data with respect to product performance andoperational stability in the manufacturing plants. Application of engineering first principles and advanced engineering methods to gain deepunderstanding of the underlying technical issues, and to propose and implement robustsolutions Synthesize, develop, update, and optimize designs based on understanding design space.Understand design options and trade-offs; managing critical parameters; leverage strongengineering fundamentals and tools. Incorporate manufacturing principles early in thedevelopment process. Executes Continuous Improvement projects in the following (but not limited to) areaso Equipment or method troubleshooting/repairso Coordinates with Test Method Development and Verification & Validation team forequipment and method validationso Method or Equipment Upgradeso Fixture maintenanceo Drawing or Specification modifications Responsible for Complete end to end maintenance of test equipment and management ofTest method validation records Ensure deliverables are reliable across the design space, is adequately pressure-tested tosatisfy user, regulatory and business requirements. Understand system and subsystemdesign sensitivity and identify and address early any potential design integration andtransfer risks. Implement DFSS rigor throughout the design selection and development process,leveraging and deploying empirical, statistical, and analytical tools to drive informed designdecisions and reduce design iteration cycle times. Optimize product design, material selection, product features, process design and humanfactorneeds based on the project needs. Analyze the design and utilize robust engineering principles to ensure that the design isoptimized to satisfy product and business requirements. Should be able to work on drawings, modeling using CAD packages. Ensure the design considerations are embedding all applicable DFX (Design forExcellence) aspects including manufacturability, serviceability, reliability and safety. Create and document novel test methodologies and provide feedback andrecommendations for product/design changes. Actively build on personal skills, expertise, and competencies. Ensure that technicallessons are reviewed, learned, and disseminated. Coach and mentor junior engineers and technicians to execute project deliverables. Ensure compliance with BD quality policies, procedures, and practices. The incumbent will also be responsible for ensuring QMS conformance and ensure that thequality policy and objectives are met per organizational guidelines.7. Knowledge and Skillsa. Knowledge ISO 20417, ISO , ISO 13485, ISO 14971, ISO 62304 Sustenance Engineering project delivery knowledge Statistics and Verification methods Tool knowledge SAP, Master control, JDE added advantage Exposure to CAD/CAE tools (Solid Works, AUTOCAD, PRO-E, etc) specializing inmold flow, structural designs, CFD and plastics domain is desired. Good understanding of medical device product development risk managementmethodologies (EURA, FMEA, etc.) will be an added advantage. Expertise with test method development, design verification & validation strategy,and execution is required. Expertise in fixture design & development. Strong track record of technical problem solving and effective product developmentthrough expert application of engineering principles is required. Design controls expertise and experience with traditional and modern fabricationtechniques is required. Proven experience in leading CAPAs, design-defect analyses, managing nonconformancesand remediation is required. Proficiency in solid mechanics/mechanics of materials and proficiency statisticalmethods/tools is required. Experience with design standard methodologies, including advanced tolerancedesign, and design for reliability Experience and Knowledge on Medical regulatory standards Exposure to Chemistry/ Chemical Engineering and/or structural analysis andsimulation/mathematical modelling desirable.b. Skills Ability to teach others to assess project/program needs, formulate strategy, buildsupport, and execute initiatives. Strong interpersonal and influence skills. Ability to engage and mentor team members and to maximize diverse perspectivesto achieve the best outcomes. Ability to analyze, organize and present large amounts of data in a clear andconcise manner. Disciplined, detailed, and well organized with managing documentation in aregulated environment. Ability to execute concurrently multiple projects and manage priorities. Ability to work independently with global exposure is desired. Strong written and verbal communication skills. Advanced Problem-solving skills. Strong Cross-functional Project Leadership skills. Strong technical and managerial judgment. Broad and deep understanding of disciplined change control processes, regulatory,and quality requirements. Strong motivational fit. Strong fit with BD values.8. Desired / Additional Skills & Knowledge (Not essential to the job but will be anadvantage to possess) Experience in high-volume manufacturing processes is a plus. Experience developing and commercializing medical devices is a plus DFSS training or certifications are a plus.Required SkillsOptional SkillsPrimary Work LocationIND Bengaluru - Technology CampusAdditional LocationsWork Shift