Npd Engineer

AUSA MEDICAL DEVICES PVT. LTD.

Department

• Establish Processes for New product development
• Validate (IQ, OQ and PQ) processes for new product development
• Establish Manufacturing documents like RM specifications, MSDS, SOP, PFMEA, Test Methods, Control plan and Visual standards, Work Instructions etc.
• Prepare Risk Management documents
• Conduct Test Method Validations (GR&R)
• Perform Process capability analysis as per customer requirement
• Analyse design specification and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products
• Applies technical knowledge to innovate, design and develop the processes, tooling, and equipment.
• Defines and releases the deliverables as defined by Project plan and Master validation plan
• Provides design for manufacturing (DFM) input to the assembly and component specifications
• Compiles and writes training materials, develops and conducts training sessions
• Works collaboratively with appropriate departments/teams to develop processes, complete validations, and handover to regular production team
• Estimates production cycle times, resource requirements and related costs to provide information for management decisions
• Analyses data for process investigation, productivity improvements, cost analysis, regulatory filings; documents and communicates results
• Purchase order review and contract review related to new product development
• Review product data sheet and new product development plan
• Coordinating with CFT team
• Review of Customer Drawings and Internal drawings for every process
• Preparing Design of Experiment (DOE) Test Protocols and Report
• Defines and releases the Installation, Process Characterization, Operational and Performance Qualification (IQ/PCS/OQ/PQ) Test Protocols and Reports
• Preparing Trial Work Order
• Preparing FAIR, Incoming, and final inspection reports
• Preparing Risk Analysis Report
• Verifying Tools, Jigs and Fixture
• Preparing Fixture validation reports
• Preparing Device Master Record and Master validation plan
• Preparing Re-validation reports
• Preparing Engineering change request and Document change request
• Preparing Certificate of conformance and Packing labels for NPD parts
• Preparing purchasing request
• Performs other related duties as assigned by the management

Qualifications:

• BE Mechanical Engineering or Bio Medical Engineering and 5+ years of process development/ Improvement experience
• Demonstrated cross functional team work in technically demanding environment
• Demonstrated ability to develop processes from concept to production

Skills and Knowledge:

• Highly motivated individual that can independently drive deliverables to completion through collaboration among team members
• Demonstrated ability to develop and drive innovative solutions into processes and products
• Problem Solving - Able to identify problems and use Lean tool to solve the problem
• Proficient in Excel, Word, Power Point and MS office/PC applications
• Teamwork Able to work cross functions to support for assigned tasks.
• Attitude Positive thinking and keep learning to improve personal skill.
• Process capability analysis through Minitab software
• ISO 13485, Manufacturing of Medical Equipment and Medical regulatory standards
• Excellent written and oral communication skills
• Strong organizational and Analytical skills
• Ability to manage priorities and work flow
• Demonstrated ability to plan and organize projects
• Good judgement with the ability to make timely and sound decisions
• Creative, Flexible, and Innovative team player
• Working knowledge of data collection, data analysis, evaluation, and scientific method
• Metrology, GD&T and Measurement
• Product and Process
• Data integrity
• Quality Tools (8D, PFMEA, SPC, MSA)

Competencies: