Job Description

Locations

• Bengaluru, Karnataka, India

Salary

Skills Required

• proficiency in spotting Design Variance through relevant statistical measuresintermediate
• experience in medical device or other regulated industryintermediate
• experience with six sigma and lean methodologiesintermediate
• experience in Medical Devicesintermediate
• work on drawings, modeling using CAD packagesintermediate

Required Qualifications

• Full time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial & Production, Chemical, Materials Engineering) (degree in a relevant engineering field is required)
• or Master Degree in a relevant engineering field is an added advantage. (degree in master degree in a relevant engineering field is an added advantage)
• 5 to 8 years of experience in medical device or other regulated industry supporting product development/ sustenance engineering projects (experience, 8 years)

Preferred Qualifications

• Exposure to six sigma and lean methodologies would be an advantage. (experience)
• Candidates with prior experience in Medical Devices will be preferred. (experience)

Responsibilities

• Drive R&D efforts through all phases of product development
• Translate customer and operational requirements into verifiable product requirements andspecifications
• Drive design optimization at the intersection of material, form factor, process, and humanfactors 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 cyclemanagement/ Sustenance engineering.
• Coordinate with the cross-functional teams (i.e., D&D, Systems Engineering, Marketing,Quality, Regulatory, Manufacturing Technology, Operations etc.) to deliver the designsolutions.
• Develop technical design and/ or verification documentations, draft engineering and testplans, drawings, 3D models as needed.
• Follow Design Control & ensure compliance with all local, state, federal, international, andinternal safety regulations, policies, and procedures.
• Define, plan and lead activities for test method & measurement system development andvalidation, and testing optimization in support of Design Verification.
• Lead creation and execution of verification protocols, summarize results, enable formaldesign 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 andoperational stability in the manufacturing plants.
• Application of engineering first principles and advanced engineering methods to gain deepunderstanding of the underlying technical issues, and to propose and implement robustsolutions
• Synthesize, develop, update, and optimize designs based on understanding design space.
• Understand design options and trade-offs; managing critical parameters; leverage strongengineering fundamentals and tools.
• Incorporate manufacturing principles early in thedevelopment 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.

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