Manufacturing Engineer – Medical Devices

6 days ago

bangalore, 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, 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.

  • Manufacturing Engineer – Medical Devices

    2 weeks ago

    bangalore, 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...

  • Principal Mechanical Engineer – Medical Devices

    3 weeks ago

    bangalore, India Quest Global Full time

    Senior Technical Architect – Medical Devices P- Mechanical Technical Lead – Medical Devices P- Senior Technical Architect – Medical Devices P- Key Responsibilities • Mechanical Design Engineer with 15-20 Years of experience Minimum 8 years’ experience in medical devices, Renal dialysis machines and consumables design . Hands on experience in all...

  • Design Engineer II

    2 days ago

    bangalore, India Becton Dickinson Medical Devices Full time

    Job Description SummaryThe Design Engineer will assist the design and engineering solutions for high-volume medical device products. (S)he, under the mentorship of a lead or senior engineer, will deliver relevant solutions to new and existing products through design iterations, risk-retirement using first principles engineering, technicalanalyses/FMEA and...

  • Industrial Designer

    7 days ago

    bangalore, India IF MedTech Pvt Ltd Full time

    At IF MedTech, we are dedicated to revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive...

  • Regulatory Affairs Specialist

    2 days ago

    bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid  Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...

  • Regulatory Affairs Specialist

    10 hours ago

    Bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid  Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...

  • iOS SDET – Medical Device Testing

    2 weeks ago

    bangalore, India L&T Technology Services Full time

    Job Title:iOS SDET – Medical Device TestingExperience:5+ YearsLocation:Bangalore Job Description:We are seeking a highly skilled iOS Software Development Engineer in Test (SDET) with a strong background in medical device testing. The ideal candidate will have hands-on experience in automated testing for iOS applications using XCTest/XCUITest with Swift or...

  • Quality & Regulatory Lead- Medical Devices

    6 days ago

    Bangalore Division, India Michael Page Full time

    Opportunity to lead QA RA for medical implants greenfield projectSet up and maintain the Quality Management System in ISO 13485About Our ClientGlobal medical devices client in the space of orthopedic implantsJob DescriptionRegulatory Affairs:Lead interactions with Indian health authorities (CDSCO) for the registration and continued compliance of our implants...

  • iOS SDET – Medical Device Testing

    2 weeks ago

    bangalore, India L&T Technology Services Full time

    Job Title: iOS SDET – Medical Device Testing Experience: 5+ Years Location: Bangalore Job Description: We are seeking a highly skilled iOS Software Development Engineer in Test (SDET) with a strong background in medical device testing . The ideal candidate will have hands-on experience in automated testing for iOS applications using XCTest/XCUITest with...

  • iOS SDET – Medical Device Testing

    13 hours ago

    bangalore, India L&T Technology Services Full time

    Job Title: iOS SDET – Medical Device Testing Experience: 5+ Years Location: Bangalore Job Description: We are seeking a highly skilled iOS Software Development Engineer in Test (SDET) with a strong background in medical device testing . The ideal candidate will have hands-on experience in automated testing for iOS applications using XCTest/XCUITest with...