Lead Design Engineer

Becton Dickinson; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

BD in Bengaluru is seeking a Lead R&D engineer to drive end-to-end product development, from concept through verification, validation and transfer to manufacturing. You will coordinate cross-functional teams to ensure requirements are verifiable and design controls are rigorously applied.

The role requires 7–12 years in engineering with strong project leadership, Six Sigma/DFSS exposure, and experience in medical devices. Knowledge of CAD/CAE tools and advanced analysis is important.

Qualifications

• 7–12 years of experience in engineering/technical field with project and team leadership.
• Master’s degree in a relevant engineering field is an added advantage.
• Six Sigma/DFSS knowledge and experience in medical devices preferred.

Responsibilities

• Lead R&D efforts through all phases of product development.
• Implement DFSS rigor and drive design verification/validation activities.
• Coordinate cross-functional teams to ensure design controls compliance.

Skills

Leadership

Project management

Cross-functional collaboration

DFSS

Education

Bachelor’s degree in engineering

Master’s degree

Tools

CAD/CAE tools

SolidWorks

MATLAB

Job description

Job Description

Job Description General Function Lead R&D efforts through all phases of product development 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: 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 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.

Education and Experience

Education 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. 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.

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. 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. Team orientation. Strong skills in project planning and management. Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements. Strong motivational fit. Strong fit with BD values.

Desired / Additional Skills & Knowledge

• 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.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Equal Opportunity Statement

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

IND Bengaluru - Technology Campus Additional Locations Work Shift

Company Overview

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.