R&D Engineer

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.

Educational Qualification:

• 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.

All your information will be kept confidential according to EEO guidelines.