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.

  • Senior Sales Executive- Medical Devices

    1 week ago

    Bengaluru, Karnataka, India BL Lifesciences Full time ₹ 8,00,000 - ₹ 20,00,000 per year

    Company DescriptionBL Lifesciences is a prominent medical device manufacturer and distributor, part of the BL Group with an 80-year legacy in medical innovation. Headquartered in New Delhi, India, with 11 offices nationwide and an international presence in Singapore, the company delivers high-quality medical devices and equipment. Expertise spans areas such...

  • Senior Technical Architect – Medical Devices

    2 weeks ago

    Bengaluru, Karnataka, India Quest Global Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Requirements At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that...

  • Area Sales Manager- Medical Devices

    1 week ago

    Bengaluru, Karnataka, India BL Lifesciences Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Company DescriptionBL Lifesciences is a leading medical device manufacturer and distributor devoted to delivering innovative products across various medical sciences. With its headquarters in New Delhi, India, and 11 offices countrywide, alongside an international office in Singapore, BL Lifesciences leverages decades of experience from its nearly...

  • Senior Technical Architect – Medical Devices

    2 weeks ago

    Bengaluru, Karnataka, India Quest Global Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Requirements At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that...

  • Bio-Medical Engineer

    1 week ago

    Bengaluru, Karnataka, India Philips Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job TitleBio-Medical EngineerJob DescriptionThe Biomedical Engineer will play a critical role in ensuring the seamless integration and functionality of medical devices within clinical environments. This position requires strong technical expertise in biomedical systems, communication protocols, and regulatory compliance, along with the ability to collaborate...

  • Bio-Medical Engineer

    1 week ago

    Bengaluru, Karnataka, India Philips Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job TitleBio-Medical EngineerJob DescriptionThe Biomedical Engineer will play a critical role in ensuring the seamless integration and functionality of medical devices within clinical environments. This position requires strong technical expertise in biomedical systems, communication protocols, and regulatory compliance, along with the ability to collaborate...

  • Device Integration engineer for medical domain

    5 hours ago

    Bengaluru, Karnataka, India Quest Global Full time ₹ 8,00,000 - ₹ 24,00,000 per year

    Job Requirements Job Title: Device Integration engineer for medical domainAt Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world...

  • Manufacturing Engineer

    2 weeks ago

    Bengaluru, Karnataka, India GE HealthCare Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryManufacturing Engineer to join our Medical Equipment Operations team, focusing on Molecular Imaging and Computed Tomography (CT) Equipment's. This role is critical in driving product excellence, process efficiency, quality & regulatory compliance in a dynamic manufacturing environment.GE HealthCare is a leading global medical...

  • Sales Executive/Area Sales Manager-Medical Devices

    6 days ago

    Bengaluru, Karnataka, India B L Lifesciences Pvt Ltd Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company DescriptionEstablished in 1984, B L Lifesciences Pvt Ltd is part of the 75-year-old BL Group of Companies. Widely recognized as India's leading manufacturer and distributor of disposable devices for Anesthesia, Critical Care, Cardiovascular Surgery, Interventional Procedures, Dialysis, and Respiratory Care, B L Lifesciences has over 31 years of...

  • Principal DFT Engineer

    1 week ago

    Bengaluru, Karnataka, India Analog Devices Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    About Analog DevicesAnalog Devices, Inc. (NASDAQ:ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate...