Medical Device Development Expert

1 day ago

Madurai, Tamil Nadu, India beBeeMedical Full time ₹ 18,42,000 - ₹ 22,49,000
Job Opportunity: Medical Device Development Specialist

The role involves leading the development of medical devices for Meter Dose Inhaler dosage form, coordinating with manufacturers to select appropriate devices, and ensuring design verification complies with user requirements.

The ideal candidate will be responsible for developing test methods and fixtures, relevant testing, validation, in-silico clinical simulations for patient safety, efficacy, and clinical outcomes. Additionally, they will support commercial product development for MDI portfolio.

In this role, the specialist will also lead the development of injectable drug-device combination products, custom design and troubleshoot delivery devices, build in-vitro setups, and analyze drug delivery performance. Furthermore, they will conduct lab experiments to validate simulation results, possess mechanical force testing expertise, and design fixtures and test methods.

Key Responsibilities:

  • Lead device workstream for Metered Dose Inhaler Dosage form from device selection, development, troubleshooting to regulatory submissions and commercial support.
  • Support development of injectable drug-device combination products.
  • Custom design and design troubleshooting of delivery devices.
  • Build in-vitro setups, test various design iterations, and analyze drug delivery performance.
  • Mechanical Force testing expertise and ability to design fixtures and test methods.
  • Familiarity with aerosol testing methodologies.
  • Drug deposition modeling and predictions, familiarity with CFD, FEA tools.
  • CFD interpretation from modelling data.
  • Design history and clinical simulation documentation.
  • Building protocols for patient-specific devices or robustness and compiling information as per latest regulatory guidance and thinking.
  • Design History File (DHF) per Design Controls, support documentation for combination products.

Requirements:

  • Bachelor's degree in Engineering (Mechanical preferable).
  • Relevant experience: Approximately 12 years in medical device development or drug delivery devices in pharmaceutical industry.
  • Knowledge in medical devices/combo product development.
  • Authoring Design History file.
  • Test Method development & validation.
  • Knowledge on Primary container closures system and regulatory expectations.

About the Role:

This is an exciting opportunity to join a global pharmaceutical company dedicated to making high-quality medicines accessible to everyone. Our team is passionate about innovation and customer satisfaction.

  • Senior Medical Device Specialist

    3 days ago

    Madurai, Tamil Nadu, India beBeeLeadership Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Job Title: Medical Segment LeadAbout the Role:We are seeking a seasoned professional to lead and grow our Medical Segment in India. The ideal candidate will bring deep domain expertise in medical devices, strong understanding of regulatory frameworks, and proven track record in managing cross-functional teams across product development, compliance, and...

  • Cloud-Based Medical Device Developer

    7 days ago

    Madurai, Tamil Nadu, India beBeeBackend Full time ₹ 16,00,000 - ₹ 24,00,000

    Full-Stack Developer PositionAs a Full-Stack Developer, you will play a crucial role in revolutionizing the healthcare industry through cutting-edge medical device design and development. Our team collaborates with experts across various domains to bring innovative solutions that enhance healthcare and improve lives.Key Responsibilities:Develop and optimize...

  • Medical Device Specialist

    7 days ago

    Madurai, Tamil Nadu, India beBeeMedicalDevice Full time ₹ 10,08,000 - ₹ 12,15,000

    Medical Device SpecialistA medical device specialist is responsible for ensuring the reliability and functionality of medical equipment used in patient care. They are electro-mechanical technicians who install, inspect, calibrate, maintain, and repair medical devices such as patient monitors, ventilators, X-ray machines, and ultrasound equipment.Main...

  • Senior Medical Devices Professional

    1 week ago

    Madurai, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 25,00,000 - ₹ 30,00,000

    Senior Medical Devices ProfessionalThe ideal candidate will possess a strong background in quality management and regulatory affairs within the medical devices industry.Main ResponsibilitiesEnsure compliance with relevant regulations through assessments and audits of medical devices.Collaborate with cross-functional teams to identify and mitigate risks...

  • Senior Mechanical Designer

    1 week ago

    Madurai, Tamil Nadu, India beBeeMechanical Full time ₹ 60,00,000 - ₹ 90,00,000

    Job OpportunityWe are seeking a highly skilled Mechanical Design Engineer to join our Product Development team for medical device development.The ideal candidate will have hands-on experience in mechanical design, with strong proficiency in 3D modeling using SolidWorks along with Ansys or Hypermesh.Main ResponsibilitiesLead mechanical design efforts for...

  • Medical Device Quality Assurance Expert

    2 days ago

    Madurai, Tamil Nadu, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,00,000

    Quality Management ProfessionalA Quality Assurance Specialist plays a crucial role in ensuring products meet quality, safety, and regulatory standards by implementing and maintaining a Quality Management System (QMS).Key ResponsibilitiesImplementing and maintaining a QMS to ensure compliance with ISO 13485 and other relevant medical device...

  • Medical Devices Complaints Specialist

    3 days ago

    Madurai, Tamil Nadu, India beBeeComplaints Full time ₹ 80,00,000 - ₹ 1,20,00,000

    PMS Analyst Job OverviewMedical device customer allegations in complaints management systems require skilled professionals. To address these allegations, a candidate must have knowledge of Medical devices usage and Medical devices reporting including post-market surveillance (PMS).Key Responsibilities:Work on medical devices complaint handling...

  • Medical Devices Compliance Specialist

    2 weeks ago

    Madurai, Tamil Nadu, India beBeeCompliance Full time ₹ 4,00,000 - ₹ 8,00,000

    Job Title: Medical Devices Compliance SpecialistAbout the Role:We are seeking a highly skilled Medical Devices Compliance Specialist to join our team. In this role, you will be responsible for handling medical device customer allegations in complaints management systems.Your Key Responsibilities:To work on medical devices Complaints handling Process.Organize...

  • Medical Devices Compliance Specialist

    4 days ago

    Madurai, Tamil Nadu, India beBeeRegulation Full time ₹ 75,00,000 - ₹ 1,50,00,000

    We are seeking an experienced professional to join our team as a Medical Devices Complaints Specialist. The ideal candidate will have a strong background in medical device regulations and experience in complaints management.Job DescriptionThe successful candidate will be responsible for handling medical device customer allegations in a complaints management...

  • Senior Design Engineer

    1 week ago

    Madurai, Tamil Nadu, India beBeeMechanicalDesigner Full time ₹ 6,00,000 - ₹ 10,00,000

    Job Summary:We are seeking a talented Mechanical Designer to join our New Product Development (NPD) team for medical device development.The ideal candidate will have 3-5 years of experience in mechanical design, with strong proficiency in 3D modelling, specifically using SolidWorks along with Ansys or Hypermesh.Key Responsibilities:Lead mechanical design...