Manufacturing Engineer – Medical Devices

5 days ago

Bengaluru, Karnataka, India Tata Consultancy Services Full time ₹ 12,00,000 - ₹ 36,00,000 per year

We are hiring for Manufacturing Engineer – Medical Devices.

Experience Range - 8 to 10 years.

Location - Bangalore, Pune, Kolkata, Chennai, Bhubaneswar, India

Job 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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