Job Description Summary

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.
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. Candidates with
prior experience in Medical Devices will be preferred.

Job Description

Drive R&D efforts through all phases of product development  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 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.

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift