Location
Bangalore | India
Job description
Job Description Summary
Job Description
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 Responsibilities - 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.
- 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
- 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.
Primary Work Location
IND Bangalore - Technology Campus
Additional Locations
Work Shift
Job Category: Engineering
Job tags
Salary
