Project Research Engineer (Mechanical Reliability)

About BETIC

The Biomedical Engineering Technology Innovation Centre (BETIC) at IIT Bombay is a leading research facility focused on creating high-quality, affordable medical devices through innovation. By bringing together experts from various disciplines, BETIC excels in identifying medical needs, developing solutions, and delivering tested and qualified products to the market 

Role Overview

The Mechanical Reliability Engineer will ensure the safety, durability, and lifecycle reliability of medical devices developed within the BETIC ecosystem at IIT Bombay. The candidate should have a deep appreciation of the essence of reliability engineering, understanding how it influences product safety, performance, and user trust, and applying this mindset throughout design, testing, and development of medical devices. The role focuses on early-stage reliability engineering, failure analysis, accelerated testing, and risk mitigation during R&D, prototyping, and clinical readiness, supporting robust regulatory submissions and smooth technology transfer to licensed manufacturing partners

The engineer will work closely with clinicians, electronics designers, embedded engineers, mechanical teams, industrial designers, startups/industry partners, testing laboratories, and regulatory teams to identify failure mechanisms, improve design robustness, and ensure dependable device operation in high-risk healthcare environments

Key Responsibilities

1. Define and derive reliability requirements for medical devices based on clinical use scenarios, regulatory standards, and real-world operating and environmental conditions
2. Perform quantitative reliability modeling, stress–strength analysis, and service-life prediction for mechanical and electromechanical subsystems
3. Establish and justify design margins, derating strategies, safety factors, and load envelopes for safety-critical components
4. Plan, execute, and oversee reliability, durability, accelerated life (ALT/HALT), vibration, thermal cycling, and thermal shock testing across development and validation phases
5. Perform advanced non-destructive testing and evaluation (NDT/NDE) using Eddy Current Array and Phased Array Ultrasonic techniques, and apply thermal imaging, DIC, and optical methods for failure analysis
6. Correlate experimental test results, inspection findings, and field feedback with ANSYS structural, thermal, fatigue, and vibration simulations to identify failure mechanisms and drive design improvements
7. Support verification and validation (V&V) activities by defining test protocols, acceptance criteria, and generating reliability and durability evidence aligned with ISO, IEC, and BIS standards
8. Prepare technical reports and reliability justifications supporting regulatory readiness, including CDSCO submissions, ISO 13485 audits, and CE marking (as applicable)
9. Use Python for reliability data analysis, Weibull modeling, statistical evaluation, visualization, and automation; maintain metrics such as MTBF, failure rates, Weibull parameters, and RPNs
10. Support risk management activities aligned with ISO 14971 by identifying reliability risks, trends, and mitigation strategies
11. Support verification & validation (V&V) and regulatory readiness (CDSCO, ISO 13485, CE) for mechanical subsystems, and prepare reliability reports, SOPs, and DHF documentation in collaboration with cross-functional teams
12. Train and mentor team members on reliability testing procedures, use of measurement and characterization equipment, best practices in mechanical reliability, and product development processes, fostering skill development, knowledge transfer, and collaborative expertise across the organization
13. Support compliance testing by assisting in preparation, execution, and documentation of regulatory and safety tests for mechanical subsystems, ensuring alignment with standards such as ISO 13485, IEC 60601, and other relevant medical device regulations
14. Support broader job activities by representing the team at industry exhibitions, vendor meetings, compliance testing sites, and laboratory activities, traveling as required, and actively participating in in-house events such as MEDHA, MEDIC, exhibitions, etc., to promote knowledge sharing, collaboration, and organizational engagement

Required Qualifications

Education

1.  Bachelor’s or Master’s degree in Mechanical / Mechatronics / related engineering

Experience

1. 3+ years in reliability engineering, testing or mechanical design
2. Experience in medical devices, healthcare products, aerospace, automotive, or safety-critical systems preferred
3. Demonstrated applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive
4. Demonstrated ability to manage and lead complex or broad scope projects
5. Demonstrated results orientation, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines
6. Demonstrated verbal, written and interpersonal skills
7. Demonstrated problem solving and troubleshooting skills
8. Applied knowledge of Microsoft Office software including Excel, Word and Power Point

Why Join BETIC?

1. Work on life-saving indigenous medical technologies
2. Direct exposure to clinical environments and programs such as BIRAC, ICMR, DBT, and RGSTC, etc. to gain hands-on experience in medical device development and evaluation
3. Opportunity to contribute across the product lifecycle, from concept and design through reliability testing and clinical validation, supporting the development of safe and robust medical products
4. Be part of one of India’s leading med-tech innovation ecosystems at IIT Bombay