Job Description Summary

The Senior Engineer will be a key member of the Product Engineering or Product Development Team, contributing to both new product design and optimization of existing products.t he role involves full lifecycle design engineering responsibilities, from concept through design transfer and into manufacturing.
The associate will work with the Design Verification Team on Strategy development and Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation, and Design Transfer activities. 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

Job Description

What Makes This Opportunity Unique

As a Senior Engineer at Becton, Dickinson and Company, you can spearhead innovative R&D projects, pioneer product advancements, and shape life-saving medical device progress.

Job Responsibilities

Product Development & Building Engineering

• Lead R&D efforts through all phases of product development.
• Translate customer and operational needs into verifiable product requirements and specifications.
• Drive development optimization considering material selection, form factor, process capabilities, and human factors.
• Apply DFSS rigor and Build for Excellence (BFX) principles throughout the development and building process.
• Evaluate system performance and reliability using engineering first principles and advanced analytical methods.
• Take part in composing activities across new product development, life cycle management, and sustenance engineering.

Collaboration across different functions

• Coordinate with cross-functional teams including Build & Development, Systems Engineering, Marketing, Quality, Regulatory, Manufacturing Technology, and Operations.
• Ensure build solutions meet user, regulatory, and business requirements.

Develop Control & Documentation

• Develop user documentation such as build and verification plans, engineering drawings, and 3D models.
• Ensure conformity to BD’s Invention Control procedures and relevant safety regulations.
• Own and maintain the Build History File (BHF) for verification activities.

Verification & Test Method Development

• Define, plan, and lead test method and measurement system development, validation, and optimization.
• Develop and implement verification protocols, summarize results, and assist in formal design reviews.
• Ensure product requirements are testable and measurable.
• Interpret and analyze building verification data to assess product performance and manufacturing stability.
• Demonstrate proficiency in identifying build variance using statistical tools.

Engineering Excellence & Continuous Improvement

• Apply robust engineering principles to optimize product development, features, and processes.
• Incorporate manufacturing principles early in the development process.
• Implement ongoing improvement projects in areas such as equipment/method troubleshooting and upgrades, fixture maintenance, drawing/specification modifications, and test method validation record management.

Test Equipment & Methodology

• Retain complete accountability for validating test equipment and test method records.
• Build and detail innovative test methodologies and offer feedback for design enhancements.

Mentorship & Compliance

• Coach and mentor junior engineers and technicians.
• Ensure conformity to BD’s Quality Management System (QMS), policies, and procedures.
• Foster an environment that cultivates ongoing technical progress and skill improvement.

Required Qualifications

• Bachelor’s Degree in Mechanical or Biomedical Engineering plus 5-8 years experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
• Proven track record of technical problem solving and effective product development.
• Expertise in building controls for medical or regulated industry experience.
• Proficient in statistical methods and tools, e.g. Mintab
• Proficient in solid mechanics and mechanics of materials.
• Familiarity with traditional and modern fabrication techniques 
• Proven experience in leading CAPAs, design-defect analyses, managing nonconformances and remediation is required.
• Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.) will be an added advantage.
• Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards. 

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift