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.