Manufacturing Engineer – Medical Devices

10 hours ago

New Delhi, India Tata Consultancy Services Full time

We are hiring for Manufacturing Engineer – Medical Devices.Experience Range - 8 to 10 years.Location - Bangalore, Pune, Kolkata, Chennai, Bhubaneswar, IndiaJob description -- 8+ years’ relevant experience in manufacturing (preferably in medical device/Pharma) with strong knowledge in various manufacturing process. - Experience in creating manufacturing process plans, process verification & validation, and equipment qualification (IQ/OQ/PQ) protocols & reports. - Experience in creating the process risk management documentation such as process FMEAs. - Experience in product variants and setting up the Bill of Material and routers. - Experience in working with cross functional team such as packaging, labeling etc. - Exposure to EU MDR and FDA requirements is preferred. - Experience with chemical products such as liquid and powder. - Proficient with MS Office applications such as MS Word, PowerPoint, Excel. - Candidate should possess strong communication and inter-personal skills. - Candidate must be able to perform assigned responsibilities independently with minimal guidance. - Candidate must be flexible to accommodate additional effort needed to meet project and organizational deadlines.Roles & Responsibilities- Create/update manufacturing process plans, work instructions, manufacturing process specification, Validation documents etc. - Perform Gap assessment between the legacy process validation and current standard. Coordinate with team for the gap remediation. - Assess the consumables in each process step and coordinate with supplier for any relevant information/documents/certificates. - Responsible for BoM (Bill of Material) and Router set up/updates for different variants of products. - Coordinate for equipment procurement and perform qualifications (IQ/OQ/PQ), validation reports, equipment CSV etc. - Coordinate with various sites/suppliers for sample planning, ordering, procurement, receiving inspection. - Collaborate with stakeholders to develop test methods/Inspection procedures. - Coordinate with cross-functional team for packaging assessment, microbiology assessment, Process verification/qualification. - Create/update risk management documentation (process FMEAs) as per the client procedure. - Provide essential information to regulatory to support in audit activity. - Responsible for all relevant document approvals and closure in the PLM system. - Effectively translate customer requirement into logical inputs for teams based remotely, including offshore team. - Responsible for adherence to timelines in a project environment and ensure project milestones are achieved. - Coordinate with site leads for the execution strategy. Participate in weekly meetings with R&D team. - Maintain and present self and team matrices to Client and TCS management in structured and timely manner.Report issues to the Client and TCS management to ensure appropriate closure.

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