Design Engineer
Job Description
- Minimum 6-7 years experience in Mechanical designing
- Proven experience in drawing checker role using CREO tool is must.
- Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable)
- Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.
- Manage electronic document control and version control on all project related documents.
- Ensure adherence to the quality systems and design assurance SOPs and customer's PLCP.
- Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective communicator or team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
More Info
Key Skills
Software Validation Plan
CAPA Systems
Design Assurance SOPs
Field Assessment Plan
Use and Design FMEA
Risk Management Plan
Project Design Development Plan
About Company
Skills:
Unit Testing, Regression Testing, Embedded C, Defect Tracking, Integration Testing, Version Control, Static Analysis
Skills:
2D and 3D CAD software, low-cost automation, Creo, CAD CAM systems, Robotics, advanced manufacturing techniques, Autocad, Digitization, measurement principles for manufacturing
Skills:
PDM software, Catia, FEA software, Autocad, Ptc Creo
Skills:
npd, Creo, Dfmea
Skills:
Technical Documentation, Solidworks, 3d Cad Modeling, Sheet Metal Fabrication, Welding, Turning, Prototyping methods, Product lifecycle management, Milling, Mechanical design principles, Design for manufacturing processes, Safety standards and regulatory compliance