Lead Design Engineer
Job Description SummaryThe right candidate will be placed in the Product engineering or product development team. Role and responsibilities will include leadership and technical support to a cross-functional team (across geography and domain). This involves leading the independent project, technical discussions, decision making, driving projects in coordination with different sites, rigor in planning & execution steps, monitoring, and control.
The Lead Engineer will have to inclusively lead TCI team members and ramp up capabilities within the team. This will need hands-on execution of the project, supporting other team members, and establishing good practices for cross-platform project execution. The Lead position requires a good balance of technical expertise and interpersonal skill to ensure all stakeholders remain positively involved and the project is delivered at the right quality on time. The ideal candidate will gain product domain knowledge and establish a good teamwork mechanism to ensure effective execution of product engineering projects.
The associate will also be responsible for leading the verification strategy creation and execution to deliver high-volume single use disposable medical products. He will be responsible for end-to-end Lab Management activities for the platform. The Lead Engineer will be involved with all aspects of design engineering including new product design and optimizing existing products. In doing so the Lead 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 successful candidate will lead test method development activities encompassing measurement system development & analyses, 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.
· Lead R&D efforts through all phases of product development
· Collaborate with Design & Development, Systems Engineering and cross-functional teams to ensure product requirements are verifiable and measurable.
· Synthesize, develop, update, and optimize designs based on understanding design space. Understand design options and trade-offs; managing critical parameters; leverage strong engineering fundamentals and tools. Incorporate manufacturing principles early in the development process.
· Ensure deliverables are reliable across the design space, is adequately pressure-tested to 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, leveraging and deploying empirical, statistical, and analytical tools to drive informed design decisions and reduce design iteration cycle times.
· Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability, reliability, and safety.
· Coordinate with the cross-functional teams (i.e., D&D, Systems Engineering, Marketing, Quality, Regulatory, Manufacturing Technology, Operations etc.) to deliver the design solutions.
· Lead and ensure implementation and rigor of design control best practices with compliance to BD quality policies and procedures through appropriate communication, training, and education of sound quality assurance principals.
· Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.
· Define, plan and lead activities for test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
· Lead end to end responsibility of all the platform level testing and Lab management.
· Lead creation and execution of verification protocols, summarize results, enable formal design reviews, and own the verification portion of the Design History File.
· Demonstrate proficiency in spotting Design Variance through relevant statistical measures.
· Interpret and analyze design verification data with respect to product performance and operational stability in the manufacturing plants.
· Identify the best tools and approaches to effectively solve engineering problems to develop/optimize designs by leveraging an appropriate mix of first principles / analytical, computational, and experimental methods.
· Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions.
· Executes Continuous Improvement projects in the following (but not limited to) areas:
o Equipment or method troubleshooting/repairs.
o Coordinates with Test Method Development and Verification & Validation team for equipment and method validations
o Method or Equipment Upgrades
o Fixture maintenance
o Drawing or Specification modifications
· Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
· Actively build on personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
· Ensure compliance with BD quality policies, procedures, and practices.
· The incumbent will also be responsible for ensuring QMS conformance and ensure that the quality policy and objectives are met per organizational guidelines.
· Quality systems processes: Ensure implementation of quality systems processes including design controls and change control.
· Project planning: Ensure quality and accuracy of integrated project plans encompassing all cross-functional activities and associated resource requirements.
· Project management: Ensure comprehensive and effective project plans are developed and actively monitor progress against plans. Be accountable for the timely delivery of all project deliverables as specified in the plans.
· Budgeting: Develop detailed budgets by project plans. Manage budget diligently and be accountable to perform to the project budget.
· Stakeholder Management: Identify project stakeholders, establish, and monitor stakeholder engagement.
· Technology transfer: Ensure efficient and effective transition from research to development to manufacturing in locations throughout the world.
· Process effectiveness: Ensure appropriate processes are followed for effective and timely engagement of other parts of the company in project activities.
· Innovation: Develop and apply innovative approaches to ensure the best outcomes in all
· aspects of the role. Support an environment in which innovation can flourish through
· empowerment, encouragement, and support.
· Proactively develop, maintain & share technical knowledge in a specialized area(s), remaining up to date on current trends and best practices.
· Actively lead, mentor, and motivate team members and junior associates, while also ensuring effective cross-functional communication and engagement. Provide frequent feedback. Continue to raise the bar on the group and help associates rise to expectations.
· Develop and apply innovative approaches to ensure the effective capture, retention, and communication of technical and project knowledge generated (tacit & implicit).
· Responsible for leading, developing, and implementing critical component changes for high volume, disposable medical devices.
· Influence others: Intuitively and quickly assess people and situations and act accordingly. Demonstrate strong persuasion and timing skills. Remain open to be persuaded when appropriate.
· Inclusive work environment: Promote and leverage diversity to achieve the best outcomes.
· Leadership courage: Demonstrate and promote leadership courage by doing what is right. Engage those who disagree to persuade or be persuaded. Instill confidence in associates and customers.
Dealing with ambiguity: Demonstrate agility and action orientation when facing change and uncertainty. Effectively manage change and instill confidence.
Education and Experience:
· Full time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial & Production, Chemical, Materials Engineering) or master’s degree in a relevant engineering field is an added advantage.
· 7 - 12 years of experience in the engineering/technical field, with 3 years demonstrated project and team leadership, preferably in the medical device industry with a successful track record of project completion.
Strong exposure to six sigma and lean methodologies would be an advantage. Candidates with prior experience in Medical Devices will be preferred.
Knowledge and Skills:
· Six Sigma knowledge/Black /Greenbelt certification, DFSS, MSA
· PMP Certifications/Project Management knowledge
· ISO 20417, ISO 15223-1, 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 in mold flow, structural designs, CFD and plastics domain is desired.
· Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.) will be an added advantage.
· Expertise with test method development, validation strategy, and execution is required.
· Expertise with design verification & validation strategy development and execution is required.
· Expertise in fixture design & development.
· Strong track record of technical problem solving and effective product development through expert application of engineering principles is required.
· Design controls expertise and experience with traditional and modern fabrication techniques is required.
· Proven experience in leading CAPAs, design-defect analyses, remediation is required.
· Proficiency in solid mechanics/mechanics of materials and proficiency statistical methods/tools is required.
· Experience with design standard methodologies, including advanced tolerance design, and design for reliability.
· Working with regulatory standards
· Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modelling desirable.
· Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and execute initiatives.
· Strong interpersonal and influence skills.
· Ability to engage and mentor team members and to maximize diverse perspectives to achieve the best outcomes.
· Ability to analyze, organize and present large amounts of data in a clear and concise manner.
· Disciplined, detailed, and well organized with managing documentation in a regulated 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.
· Team orientation.
· Strong skills in project planning and management.
· Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements.
· Strong motivational fit.
· Strong fit with BD values.