Biomedical Engineer
Liefern-imprese, Bengaluru, Karnataka, India
Job Summary:-
The Biomechanical Engineer will apply principles of biomechanics, engineering, and physiology to the design, analysis, and development of medical equipment. This includes contributing to all phases of the product lifecycle, from concept generation and prototyping to testing, regulatory submissions, and post-market surveillance. The ideal candidate will have a strong understanding of human anatomy, physiology, and mechanics, as well as experience in medical device development.
Responsibilities:
* Design and develop medical devices, considering biomechanical factors such as tissue mechanics, fluid dynamics, and human movement.
* Conduct biomechanical analyses using computational modeling (e.g., FEA) and experimental techniques.
* Develop and execute testing protocols to evaluate the performance and safety of medical devices, including mechanical testing, biocompatibility testing, and clinical studies.
* Collaborate with cross-functional teams, including engineers, clinicians, regulatory personnel, and marketing, to ensure successful product development.
* Prepare and maintain technical documentation, including design specifications, test reports, and regulatory submissions.
* Stay current with the latest advancements in biomechanics, medical device technology, and regulatory requirements.
* Contribute to risk management activities, including hazard analysis and failure mode effects analysis (FMEA).
* Participate in design reviews and provide technical expertise.
* Troubleshoot and resolve technical issues related to medical device design and performance.
* Support post-market surveillance activities, including investigating device failures and implementing corrective actions.
Qualifications:
* Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field with a focus on biomechanics. Master's degree or Ph.D. preferred.
* 5 years of experience in medical device design and development, preferably in [Specific area of medical devices, e.g., orthopedics, cardiovascular, etc.].
* Strong understanding of biomechanical principles, including solid mechanics, fluid mechanics, and tissue mechanics.
* Proficiency in computational modeling software (e.g., ANSYS, Abaqus, COMSOL) and CAD software (e.g., SolidWorks, Creo).
* Experience with experimental testing techniques, including mechanical testing, material characterization, and biomechanical measurements.
* Knowledge of relevant regulatory standards (e.g., ISO 13485, FDA regulations).
* Excellent communication, interpersonal, and teamwork skills.
* Strong problem-solving and analytical skills.
* Ability to work independently and as part of a team.
Preferred Qualifications:
* Experience with specific medical device areas (e.g., implants, surgical instruments, diagnostic equipment).
* Familiarity with biocompatibility testing and sterilization methods.
* Experience with clinical studies and data analysis.
* Knowledge of statistical methods and data analysis software.
