Senior R&D Engineer – Medical Devices

4 weeks ago

Mumbai, India Tek Support Full time

Job Title: Senior R&D Engineer – Medical Devices

Location:
Mumbai, IND

Employment type:
Part-time

Position Summary:

We are seeking an experienced
R&D Engineer Trainer with 10+ years in the medical device industry
to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes.

Key Responsibilities:

  • Lead the design and development of new medical devices, from feasibility studies through product launch.
  • Oversee product development lifecycle including concept generation, prototyping, design verification & validation, risk analysis, and design transfer to manufacturing.
  • Ensure compliance with
    FDA, ISO 13485, MDR, IEC 60601, ISO 14971
    and other applicable regulations and standards.
  • Drive
    innovation
    by identifying new technologies, materials, and processes that enhance product performance and cost-effectiveness.
  • Lead technical design reviews, root cause analysis, and continuous improvement initiatives.
  • Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and Marketing to ensure successful product development and launch.
  • Manage
    design documentation
    including Design History File (DHF), Design Inputs/Outputs, and Risk Management Files.
  • Provide technical leadership and mentorship to junior engineers and project teams.
  • Interface with clinicians, key opinion leaders (KOLs), and end-users to incorporate clinical feedback into design.
  • Lead problem-solving initiatives for product performance, reliability, and usability.
  • Stay updated with medical device industry trends, regulatory changes, and emerging technologies.

Qualifications & Requirements:

  • Bachelor's or Master's degree in
    Biomedical Engineering, Mechanical Engineering, Materials Science, or related field
    .
  • 10+ years of progressive experience in R&D within the medical device industry.
  • Strong knowledge of medical device product development processes, including Design Control per 21 CFR Part 820.
  • Proven track record of successfully launching medical devices into global markets.
  • Expertise in
    CAD tools (SolidWorks/Creo/AutoCAD)
    , prototyping, and testing methods.
  • Experience with
    risk management (ISO 14971), usability engineering (IEC 62366), and biocompatibility standards (ISO 10993)
    .
  • Strong project management and leadership skills with experience in leading cross-functional teams.
  • Excellent problem-solving, analytical, and communication skills.
  • Experience with Class II and Class III medical devices preferred.

Core Competencies:

  • Innovation & Creativity in Medical Device Development
  • Regulatory & Quality compliance mindset
  • Leadership & Mentorship abilities
  • Cross-functional Collaboration
  • Strong Analytical and Technical problem-solving
  • Strategic thinking with hands-on execution

  • Medical Device Engineer

    1 day ago

    Mumbai, Maharashtra, India Ellaya Health Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Company DescriptionWe are an innovative Indian med-device company driven by the vision of creating novel solutions that improve lives. By harnessing cutting-edge engineering and deep clinical understanding, we are building a new generation of medical devices designed to address critical, underserved needs in healthcare.Our first product embodies this...

  • Medical device engineer

    3 weeks ago

    Mumbai, India Ellaya Health Full time

    Company Description We are an innovative Indian med-device company driven by the vision of creating novel solutions that improve lives. By harnessing cutting-edge engineering and deep clinical understanding, we are building a new generation of medical devices designed to address critical, underserved needs in healthcare. Our first product embodies this...

  • Technical Customer Service Manager

    2 days ago

    Navi Mumbai, India Stemtech Medical Devices Full time

    Job Title: Technical Customer Service Manager – Medical DevicesLocation: Mumbai, IndiaRole Summary:We are seeking an experienced Service Manager to lead our medical device serviceoperations. This individual will be responsible for scheduling and maintaining preventivemaintenance, coordinating with hospitals, troubleshooting technical issues, and...

  • Technical customer service manager

    3 days ago

    Navi Mumbai, India Stemtech Medical Devices Full time

    Job Title: Technical Customer Service Manager – Medical DevicesLocation: Mumbai, IndiaRole Summary:We are seeking an experienced Service Manager to lead our medical device serviceoperations. This individual will be responsible for scheduling and maintaining preventivemaintenance, coordinating with hospitals, troubleshooting technical issues, and...

  • Technical Customer Service Manager

    3 days ago

    Navi Mumbai, India Stemtech Medical Devices Full time

    Job Title: Technical Customer Service Manager – Medical DevicesLocation: Mumbai, IndiaRole Summary:We are seeking an experienced Service Manager to lead our medical device serviceoperations. This individual will be responsible for scheduling and maintaining preventivemaintenance, coordinating with hospitals, troubleshooting technical issues, and...

  • Medical Device Engineer

    3 weeks ago

    Mumbai, India Ellaya Health Full time

    Company DescriptionWe are an innovative Indian med-device company driven by the vision of creating novel solutions that improve lives. By harnessing cutting-edge engineering and deep clinical understanding, we are building a new generation of medical devices designed to address critical, underserved needs in healthcare.Our first product embodies this...

  • R&d Assistant

    2 days ago

    Malad, Mumbai, Maharashtra, India D R Coat and Resins Full time

    R&D ASSISTANT Location: Mumbai (Western Line Preferred) Qualifications: Minimum M.Sc. in Science or Chemistry (or a related discipline). **Experience**: Minimum 3 years of relevant experience handling TDS (Technical Data Sheets) and MSDS (Material Safety Data Sheets). Preferred experience in the chemical, manufacturing, or related industries. **Key...

  • Technical Customer Service Manager

    3 days ago

    Navi Mumbai, Maharashtra, India Stemtech Medical Devices Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title: Technical Customer Service Manager – Medical DevicesLocation: Mumbai, IndiaRole Summary:We are seeking an experienced Service Manager to lead our medical device serviceoperations. This individual will be responsible for scheduling and maintaining preventivemaintenance, coordinating with hospitals, troubleshooting technical issues, and...

  • Medical Device Engineer

    3 weeks ago

    Mumbai, India Ellaya Health Full time

    Company DescriptionWe are an innovative Indian med-device company driven by the vision of creating novel solutions that improve lives. By harnessing cutting-edge engineering and deep clinical understanding, we are building a new generation of medical devices designed to address critical, underserved needs in healthcare.Our first product embodies this...

  • Medical Device Engineer

    3 weeks ago

    Mumbai, India Ellaya Health Full time

    Company Description We are an innovative Indian med-device company driven by the vision of creating novel solutions that improve lives. By harnessing cutting-edge engineering and deep clinical understanding, we are building a new generation of medical devices designed to address critical, underserved needs in healthcare. Our first product embodies this...