Job Description

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

Role and responsibilities will include leadership and technical support to a cross-functional team (across geography and domain).

This involves leading the independent project, technical discussions, decision making, driving projects in coordination with different sites, rigor in planning & execution steps, monitoring, and control.

The Lead Engineer will have to inclusively lead TCI team members and ramp up capabilities within the team.

This will need hands-on execution of the project, supporting other team members, and establishing good practices for cross-platform project execution. The Lead position requires a good balance of technical expertise and interpersonal skill to ensure all stakeholders remain positively involved and the project is delivered at the right quality on time. The ideal candidate will gain product domain knowledge and establish a good teamwork mechanism to ensure effective execution of product engineering projects.

The associate will also be responsible for leading the verification strategy creation and execution to deliver high-volume single use disposable medical products.

The Lead Engineer will be involved with all aspects of design engineering including new product design and optimizing existing products. In doing so the Lead 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 successful candidate may lead 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.



Education

Full time Degree in a relevant engineering field is required (i.e., Mechanical, Bio Medical, Materials Engineering) or master's degree in a relevant engineering field is an added advantage.

Experience 7 - 12 years of experience in the engineering/technical field, with 3 years demonstrated project and team leadership, preferably in the medical device industry with a successful track record of project completion.

Strong exposure to six sigma and lean methodologies would be an advantage.

Candidates with prior experience in Medical Devices will be preferred.

General Function:

Lead R&D efforts through all phases of product development and 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 trade-offs; managing critical parameters; leverage strong

engineering fundamentals and tools. Incorporate manufacturing principles early in the

development process.

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.

Coordinate with the cross-functional teams (i.e., D&D, Systems Engineering, Marketing, Quality,Regulatory, Manufacturing Technology, Operations etc.) to deliver the design solutions.

Lead and ensure implementation and rigor of design control best practices with compliance to BD quality policies and procedures through appropriate communication, training, and education of sound quality assurance principals.

Ensure compliance with all local, state, federal, and BD safety regulations, policies, and

procedures.

Define, plan and lead activities for test method & measurement system development and

validation, fixture design and testing optimization in support of Design Verification.

Lead end to end responsibility of all the platform level testing and Lab management.

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.

Identify the best tools and approaches to effectively solve engineering problems to

develop/optimize designs by leveraging an appropriate mix of first principles / analytical,

computational, and experimental methods.

Experience solving problems, provides detailed insight and constructive criticism in complex

situations, and foresees problems along with potential solutions.

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

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.

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.
Organizational Leadership:

Quality systems processes: Ensure implementation of quality systems processes including design

controls and change control.

Project planning: Ensure quality and accuracy of integrated project plans encompassing all cross functional activities and associated resource requirements.

Project management: Ensure comprehensive and effective project plans are developed and

actively monitor progress against plans. Be accountable for the timely delivery of all project

deliverables as specified in the plans.

Budgeting: Develop detailed budgets by project plans. Manage budget diligently and be

accountable to perform to the project budget.

Stakeholder Management: Identify project stakeholders, establish, and monitor stakeholder

engagement.

Technology transfer: Ensure efficient and effective transition from research to development to

manufacturing in locations throughout the world.

Process effectiveness: Ensure appropriate processes are followed for effective and timely

engagement of other parts of the company in project activities.

Innovation: Develop and apply innovative approaches to ensure the best outcomes in all

aspects of the role. Support an environment in which innovation can flourish through

empowerment, encouragement, and support.

Organizational Development

Proactively develop, maintain & share technical knowledge in a specialized area(s), remaining up to date on current trends and best practices.

Actively lead, mentor, and motivate team members and junior associates, while also ensuring

effective cross-functional communication and engagement. Provide frequent feedback. Continue

to raise the bar on the group and help associates rise to expectations.

Develop and apply innovative approaches to ensure the effective capture, retention, and

communication of technical and project knowledge generated (tacit & implicit).
Leadership

Responsible for leading, developing, and implementing critical component changes for high

volume, disposable medical devices.
Influence others: Intuitively and quickly assess people and situations and act accordingly.

Demonstrate strong persuasion and timing skills. Remain open to be persuaded when

appropriate.

Inclusive work environment: Promote and leverage diversity to achieve the best outcomes.

Leadership courage: Demonstrate and promote leadership courage by doing what is right.

Engage those who disagree to persuade or be persuaded. Instill confidence in associates and

customers.

Dealing with ambiguity: Demonstrate agility and action orientation when facing change and

uncertainty. Effectively manage change and instill confidence
Knowledge

Six Sigma knowledge/Black /Greenbelt certification, DFSS, MSA

PMP Certifications/Project Management 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, validation strategy, and execution is required.

Expertise with design verification & validation strategy development 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, 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.

Working with regulatory standards

Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modelling desirable.

Skills

Ability to lead and 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.



Strong skills in project planning and management.

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

requirements.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

Experience in solid modelling (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.

DFSS training or certifications are a plus.
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift