Job Description

Drive R&D 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., 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.

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