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Senior Design Engineer

Becton Dickinson

Becton Dickinson

Bengaluru, Karnataka, India
Posted on Saturday, November 18, 2023

Job Description Summary

The associate will be responsible for supporting the verification strategy creation and execution to deliver high-volume single use disposable medical products. This dynamic role will have you working with cross-functional engineering teams to guide products through verification using BD’s Stage Gate framework, DFM/DFSS to deliver cost-effective design-transfer. The successful candidate will 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. The successful candidate will support associates supporting requirements management, design and development and post-launch support.

Job Description

  • 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.
  • Follow Design Control & ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
  • Interpret and analyze design verification data with respect to product performance and operational stability in the manufacturing plants.
  • The associate will work on receipt, preparation, testing, and delivery of test samples and support materials for all V&V lab associate testing including sample inventory management.
  • 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.
  • 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 tradeoffs; 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.
  • Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability, 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.
  • Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.
  • The incumbent will also be responsible for ensuring QMS conformance and ensure that the quality policy and objectives are met per organizational guidelines.
  • Coordinate the Material Shipment & Vendor management.

Education and Experience:

Bachelor’s degree in mechanical or biomedical Engineering with 5 to 8 years of experience in medical device or other regulated industry OR

Master’s degree in mechanical or biomedical Engineering and 4+ years of experience.

Knowledge and Skills:

  • Expertise with test method development, validation strategy, and execution is required.
  • Expertise in fixture design & development.
  • Expertise with design verification & validation strategy development and execution is required.
  • 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, managing non conformances and 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.
  • Experience and Knowledge on Medical regulatory standards
  • Experience in solid modeling (SolidWorks) or electromechanical systems is a plus.
  • Experience in high-volume manufacturing processes is a plus.
  • Experience developing and commercializing medical devices is a plus.
  • Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modeling desirable.
  • DFSS training or certifications are a plus.

Preferred skills:

  • Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and execute initiatives.
  • Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty.
  • Ability to engage and mentor team members and to maximize diverse perspectives to achieve the best outcomes.

Primary Work Location

IND Bangalore - Technology Campus

Additional Locations

Work Shift