Senior Design Engineer

Job Description Summary

The right candidate will be placed in the Product engineering team

The Senior Engineer will be involved with all aspects of design engineering including product change and optimizing existing products

In doing so the Senior Engineer will follow BDs Global Product Development System, Design controls 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 verification strategy creation and execution to deliver high-volume medical products

The successful candidate will also deliver on 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

Job Description

Drive RD efforts through all phases of product engineering

Participate in design efforts over the continuum of product engineering, change management and/ or life cycle management/ Sustenance engineering

Coordinate with the cross-functional teams (i

e

, DD, 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

Implement DFSS rigor throughout the change control and development process

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

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

Document:

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 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

Educational Background

Full time Degree in a relevant engineering field is required (i

e

, Mechanical and/or Material/Chemicals) or Master Degree in a relevant engineering field (Mechanical) is an added advantage

Professional Experience

5 to 8 years of experience in medical device or other regulated industry leading engineering change / product change projects

Experience in contributing/leading Design change controls, Design reviews and Design transfer

Exposure to high volume products, Product engineering and Product change management would be an advantage

Candidates with prior experience in Medical Devices will be preferred

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift