Overview
On Site
Full Time
Skills
Test Methods
Manufacturing
Laboratory Equipment
Data Analysis
Minitab
Uploading
Testing
3D Modeling
SolidWorks
Product Lifecycle Management
Plant Lifecycle Management
Root Cause Analysis
Corrective And Preventive Action
Collaboration
Agile
Medical Devices
ISO 13485
ISO 9000
Risk Analysis
Risk Assessment
Communication
Technical Support
Presentations
Management
Mechanical Engineering
Production Engineering
Research and Development
Job Details
Roles and Responsibilities:
- Prepare test protocols and completion reports.
- Conduct testing in the lab, understand flow of events and need-by timelines, coordinate and communicate with all parties and mitigate any problems that arise.
- Perform test method and fixture updates including test method validation and equipment IQs etc.
- Responsible for Initiating Build Requests with the manufacturing team.
- Knowledge about tensile strength testing, fatigue testing, pressure testing, torque testing etc.
- Knowledge about various lab equipment's like Instron tester, torque tester etc.,
- Manage Design Freeze and Design Verification testing and data analysis using Minitab.
- Manage testing based on the workload and uploading relevant documents (test results, checklists, etc.) and Images in agile.
- Troubleshoot testing issues and provide solutions to ensure continuity of verification testing.
- Support in designing the product and test fixture.
- 3D Modeling & detailing of test fixtures using SolidWorks.
- Knowledge of Product Lifecycle Management (PLM) and exposure to PLM tools like Agile, Wind-chill, Team center etc.
- Transfer of DHF deliverables to the new templates.
- Facilitate RCA and CAPA.
- Manage relationships with external vendors and suppliers for ordering components.
- Collaborate with cross-functional teams for review and approval of the deliverables and associate change orders in Agile.
- Communicate effectively with key stakeholders to ensure alignment and understanding of scope of activity and associated artifacts.
- Must know about medical device compliances, regulations & standards (ISO 13485, ISO 14971).
- Continuously evaluate and improve the processes and procedures to increase efficiency and reduce cycle time.
- Proficiency in requirement engineering, risk analysis and V&V activities.
- Participate in risk assessments and ensure product designs meet safety, regulatory and quality standards.
- Contribute to additional tasks such as design support or support any activity required in the R & D department.
- Strong communication skills, provide guidance and technical support to cross-functional support teams.
- Prepare regular updates and presentations for senior management.
- B/E. Tech in Mechanical Engineering, Production Engineering, or similar associated stream.
- Engineer having experience of 10+ years with exposure to Medical Equipment R&D process.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.