Mechanical Engineer

ASSOCIATE ENGINEER: PROCESS VALIDATION ENGINEER

Job Location: Pune

IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device manufacturing. We partner with customers to support them for all aspects of medical device Product Development Life Cycle. Employees are the key to success in our organization. We value our engineers and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology and exceptional customer service are the key enablers of our success.

POSITION DESCRIPTION:

Support IZiel Team for various requirements for product development lifecycle of medical devices from Gap Assessment, Design Control, Engineering Documentation, Process Validation (IQ, OQ, PQ, TMV, TMD). Engineer must successfully complete the customer requirements with attention to detail, within timelines and utmost quality. Engineer must communicate the project requirements, daily tasks, deliverable expectations and coordinate with global IZiel Team for completing the projects on time, within budget and within scope.

POSITION RESPONSIBILITIES:

• Associate Engineer would work with global IZiel Teams & Customer to successfully complete all deliverables within time and budget.
• Participate in daily project meetings with IZiel India Team & communicate priorities, customer requirements, ensure deliverables are completely understood and set clear expectations.
• Co-ordinate with IZiel India Team to ensure deliverables are met as per customer with an Onshore Offshore Model.
• Conduct Quality Check on deliverables from India Team prior to submitting to the customer.
• Engineer would prepare Design & Development Documents to align with the regulatory strategy.
• Engineer would prepare validation plan & report, requirements traceability matrix, equipment specifications, IQ, OQ, PQ, URS, Initial Risk Assessment, Test Method Validation, FAT, SAT etc.
• Utilize statistics to analyze data, characterize process and perform process validation activities with support from global team.
• Create or Upgrade QMS Procedures, Plans in accordance to 21 CFR 820, ISO 13485 etc.
• Resolve queries, customer concerns & drive the project to completion
• Engineer would receive on the job training of Document Preparation, Requirements Management, Risk Management along with introduction to Six Sigma, Lean Manufacturing etc.

DESIRED/PREFERRED QUALIFICATIONS:

• Bachelor Engineering Degree or any Advanced Science Degree
• Strong & Clear Communication, Presentation & Coordination Skills (Written & Oral)
• Team Player with ability to complete projects within timeline
• Attention to detail with task prioritization capabilities
• Technical Writing
• Experience with basic statistics and/or reliability methodologies
• Willingness to travel