Design Engineer II
BD
- Bangalore, Karnataka
- Permanent
- Full-time
- Participate in design efforts over the continuum of product development; Coordinate, deliver, plan & communicate R&D deliverables on the program and maintain collaborative relationships with the cross-functional team (i.e., Marketing, Quality, Regulatory, Manufacturing Technology, Operations etc.).
- Deliver design solutions to meet customer requirements and verify that specifications for product systems, subsystems, interfaces, and components meet customer requirements and maintain traceability throughout the development process.
- Deliver design solutions that optimize product design, material selection, product features, process design and human factor needs.
- Analyze the design and utilize robust engineering principles to ensure that the design is optimized to satisfy product and business requirements.
- Implement DFSS rigor throughout the design selection, optimization, and development process, leveraging and deploying empirical, statistical, and analytical tools which will improve design decisions, trade-offs, robustness and reduce design iterations and/or cycle times.
- Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, serviceability, reliability, and safety.
- Provide technical ownership for product design aspects for developmental and commercial products within the platforms throughout their entire lifecycle. Resolve technical problems. Create solutions for technical problems using systematic problem-solving methodologies and engineering principles.
- Develop subject matter expertise and stay current with new technologies and material advancements. Participate in research and assessment of the industry landscape from IP, regulatory, product, and technology standpoint. Collaborate on technical reviews at the various stages of Design and development.
- Follow Design Control for medical devices to ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
- Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
- Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.
Minimum 2 years of experience leading / supporting product development projects in Mechanical design using CAD/CAE, Chemical Engineering and Plastics.Knowledge and Skills:Knowledge
- Exposure to CAD/CAE tools (Solid works, AUTOCAD, PRO-E, etc.)
- Experience with implementing product changes through a structured, phase-gated, product development process is desired. Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.)
- Demonstrated first principles engineering and design skills (CAD/CAE).
- Ability to analyze, organize and present large amounts of data in a clear and concise manner.
- Disciplined, detailed, and well organized with managing documentation in a regulated environment.
- Ability to execute concurrently multiple projects and manage priorities.
- Ability to work independently as well as delegate appropriately.