Manufacturing Engineer – Medical Devices

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.