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
- Drive R&D efforts through all phases of product development.
- Translate customer and operational requirements into verifiable product requirements and specifications.
- Drive design optimization at the intersection of material, form factor, process, and human factors 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 cycle management/ Sustenance engineering.
- Coordinate with the cross-functional teams (i.e., D&D, Systems Engineering, Marketing, Quality, Regulatory, Manufacturing Technology, Operations etc.) to deliver the design solutions.
- Develop technical design and/ or verification documentations, draft engineering and test plans, drawings, 3D models as needed.
- Follow Design Control & ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
- Define, plan and lead activities for test method & measurement system development and validation and testing optimization in support of Design Verification.
- 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 analyse design verification data with respect to product performance and operational stability in the manufacturing plants.
- Application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
- 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.
- Executes Continuous Improvement projects in the following (but not limited to) areas.
- Equipment or method troubleshooting/repairs.
- Coordinates with Test Method Development and Verification & Validation team for equipment and method validations
- Method or Equipment Upgrades
- Fixture maintenance
- Drawing or Specification modifications
- Responsible for Complete end to end maintenance of test equipment and management of Test method validation records.
- 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.
- Optimize product design, material selection, product features, process design and human-factor need based on the project needs.
- Analyze the design and utilize robust engineering principles to ensure that the design is optimized 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 for Excellence) aspects including manufacturability, serviceability, reliability, and safety.
- 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.
- 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 the quality policy and objectives are met per organizational guidelines.
Education And Experience
Education
- Minimum bachelor's in mechanical, Materials, or Biomedical Engineering or a closely related technical field. Advanced degree preferred.
Experience
- Minimum 6-10 years of experience leading / supporting product development projects in medical device, pharma, or related industries.
- Proven hands-on experience with Design and Development of high-volume products.
- Experience or understanding of implementing product changes through a structured, phase-gated, product development process.
Knowledge And Skills
Knowledge
- Experience and expertise in Value Analysis Value Engineering (VAVE) process and methodologies, Lean Engineering, Lean Product Development methodologies and approaches.
- Experience leading / supporting product development projects in medical. device, pharma, or related industries.
- Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.).
- Experience in product innovation related to cost-savings is great to have.
Skills
- Strong interpersonal and influence skills.
- Strong written and verbal communication skills.
- Advanced Critical thinking 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.
Required Skills
Optional SkillsPrimary Work LocationIND Bengaluru - Technology CampusAdditional LocationsWork Shift
