Job Description Summary

Job Description

P3-11439

1. About BD

BD is one of the largest global medical technology companies in the world and is advancing

the world of health by improving medical discovery, diagnostics, and the delivery of care. The

company develops innovative technology, services and solutions that help advance both clinical

therapy for patients and clinical process for health care providers. BD has 70,000 employees

and a presence in virtually every country around the world to address some of the most

challenging global health issues.

2. About BD TCI

“BD, a 125-year-old global medical device company has started its Enterprise Center in

Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an

integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory,

IT and other functions. The center boasts of some of the brightest minds who work in a unique

environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD’s customers

and patients thereby contributing its bit towards “advancing the world of health”.

3. Position Summary

The right candidate will be placed in the Product development or Product engineering 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

4. Educational Background

Full time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial &

Production, Chemical, Materials Engineering) or Master Degree in a relevant engineering field

is an added advantage.

5. 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. Candidate should have good CAD & PLM Exposure. Candidates with prior experience in Medical Devices will be preferred.

6. Job Responsibilities

 Drive R&D efforts through all phases of product development . Have Strong CAD background(Component , Subassembly , Skeleton Model , Relations , CAD Standards , GD&T )

 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

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

 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 humanfactor

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.

7. Knowledge and Skills

a. 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, design verification & validation strategy,

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, managing nonconformances

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

 Exposure to Chemistry/ Chemical Engineering and/or structural analysis and

simulation/mathematical modelling desirable.

b. Skills

 Ability to 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.

 Broad and deep understanding of disciplined change control processes, regulatory,

and quality requirements.

 Strong motivational fit.

 Strong fit with BD values.

8. Desired / Additional Skills & Knowledge (Not essential to the job but will be an

advantage to possess)

 Experience in high-volume manufacturing processes is a plus.

 Experience developing and commercializing medical devices is a plus

 DFSS training or certifications are a plus.

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift