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 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 optimise 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 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 optimisation in support of Design Verification
- Lead creation and execution of verification protocols, summarise 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
- Apply engineering first principles and advanced engineering methods to gain deep understanding of technical issues and to propose and implement robust solutions
- Synthesize, develop, update, and optimise designs based on understanding of design space; understand design options and trade‑offs; manage critical parameters; leverage strong engineering fundamentals and tools; incorporate manufacturing principles early in the development process
- Execute continuous improvement projects covering equipment or method troubleshooting/repairs, coordinate 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, are adequately pressure‑tested to satisfy user, regulatory and business requirements; understand system and subsystem design sensitivity and identify/address early any potential design integration and transfer risks
- Optimise product design, material selection, product features, process design and human factor needs based on the project needs
- Analyse the design and utilise robust engineering principles to ensure design is optimised to satisfy product and business requirements
- Work on drawings, modelling using CAD packages
- Ensure design considerations embed all applicable DFX 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 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
- Ensure QMS conformance and that quality policy and objectives are met per organisational guidelines
Work Location
Primary Work Location: IND Bengaluru – Technology Campus. Additional Location(s): Work Shift.