R&D Engineer

1 week ago

Hyderabad, India Intellectt Inc Full time

R&D Engineer (Product Development) - Medical Device Industry

Location: Hyderabad, Telangana


Job Summary:

We are seeking a highly motivated R&D Engineer to join our product development team in the medical device industry. The successful candidate will play a pivotal role in the design, development, and commercialization of innovative medical devices. The ideal candidate will collaborate cross-functionally with engineering, quality, regulatory, and manufacturing teams to bring products from concept to market while ensuring compliance with industry standards.

Key Responsibilities:

  • Lead the design and development of medical devices from concept through commercialization, ensuring compliance with Design Control and regulatory standards (FDA, ISO 13485, IEC 60601, etc.).
  • Develop detailed product specifications, technical drawings, and design verification/validation protocols.
  • Conduct research and feasibility studies to explore new materials, technologies, and methodologies for product development.
  • Perform risk assessments (FMEA) and implement design improvements to mitigate risks.
  • Execute verification and validation testing, including bench testing, pre-clinical studies, and human factors evaluations.
  • Collaborate with manufacturing to ensure that designs are optimized for production (DFM/DFA) and scalability.
  • Drive innovation by identifying opportunities for intellectual property (IP) development and contributing to patent filings.
  • Prepare and present technical reports, design reviews, and project updates to stakeholders.
  • Ensure alignment of product development with regulatory, quality, and clinical requirements, adhering to Good Manufacturing Practices (GMP) and maintaining detailed design history files (DHFs).
  • Support regulatory submissions (510(k), PMA) by providing technical documentation and product performance data.
  • Troubleshoot design and production issues, using root cause analysis to implement corrective actions.
  • Stay up to date with the latest medical device regulations, standards, and industry trends to drive continuous improvement.


Required Qualifications:

  • Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
  • 3-5 years of experience in product development, preferably in the medical device industry.
  • Proficiency in CAD software (e.g., SOLIDWORKS, Pro/ENGINEER) for 3D modeling and design.
  • Hands-on experience with design verification and validation processes, including test method development.
  • Strong knowledge of Design Control processes, risk management (ISO 14971), and quality systems (ISO 13485).
  • Excellent problem-solving skills and the ability to work in a fast-paced, collaborative environment.
  • Strong communication skills and the ability to present technical information to cross-functional teams.
  • Familiarity with regulatory pathways such as FDA 510(k) or PMA submission is a plus.


Preferred Qualifications:

  • Experience with human factors engineering and usability testing.
  • Knowledge of materials science, particularly biomaterials or implantable devices.
  • Certifications in Six Sigma, Lean Manufacturing, or related process improvement methodologies.

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