Job Description Summary

Job Description

Position Summary
The right candidate will be placed in the Product engineering or product development team. 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 successful candidate will also support 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

Educational Background
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.
Professional Experience

• 5 to 8 years of experience in medical device or other regulated industry supporting product development/ sustenance engineering projects
• Exposure to six sigma and lean methodologies would be an advantage. Candidates with prior experience in Medical Devices will be preferred.

Job Responsibilities
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 analyze 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 needs based on 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 and 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.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

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