Senior Technical Lead - MDR, ISO 13485, MDD

Experience: Not Available to Not Available years

Location: Bangalore, India

Skills: ISO 13485, MDR regulations, Medical Device Directive (MDD), Weibull, Exponential, Lognormal, Chi square, Temperature cycling fatigue, Coffin Manson, Norris Landzberg, Solder joint fatigue, Arrhenius and Eyring acceleration models, Cumulative damage, Stress life methodologies, Humidity related degradation models, Peck’s model, HALT, ALT, Life Test protocols, PLM systems, Mechanical jigs, Electrical jigs, Electro-mechanical jigs, Reliability stress testing, Technical leadership, Analytical thinking, Detail oriented, Certification in Medical Device Regulations (MDR), Certification in ISO 13485

Job Summary
As a Senior Technical Lead specializing in mdr,ISO 13485, and mdd, the primary responsibilities include overseeing the technical aspects of projects related to medical device regulations and standards compliance. The role involves ensuring adherence to ISO 13485 quality management systems and the Medical Device Directive (MDD).

Key Responsibilities
1. Field Data Analytics & Statistical Modelling
• Perform field return data analysis using Weibull, Exponential, Lognormal, Chi square and other life data distributions.
• Develop failure rate predictions and reliability growth assessments.
• Identify dominant failure modes and drive corrective actions.
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2. Physics of Failure (PoF) Modelling
• Apply PoF-based reliability models such as:
o Temperature cycling fatigue (Coffin Manson, Norris Landzberg)
o Solder joint fatigue / electronics wear out
o Arrhenius and Eyring acceleration models




o Cumulative damage & stress life (S N) methodologies
o Humidity related degradation models (Peck’s model)
• Correlate predicted stresses with real-world mission profiles and test outcomes.
• Provide design guidance to mitigate wear out mechanisms and improve long-term robustness.
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3. Mission Profile Development & Reliability Test Protocols
• Build detailed mission profiles based on user setting, usage cycles, load conditions, and life expectations.
• Create HALT, ALT, Life Test protocols tailored to predicted failure mechanisms.
• Define stresses, acceleration factors, acceptance criteria, and sample sizes.
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4. Test Execution & Data Analysis
• Conduct HALT/ALT/Life tests in-house or at external labs.
• Set up test fixtures, monitor tests, ensure correct stress application, and maintain data integrity.
• Analyze test results and correlate with PoF and statistical models.
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5. Documentation & Reporting
• Generate high-quality test protocols, risk assessments, test plans, and final reports.
• Ensure all documentation meets medical device regulatory expectations.
• Maintain version-controlled reliability documentation within PLM systems.




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6. Fixtures, Jigs & Test Setup Development
• Design and develop mechanical, electrical, and electro-mechanical jigs/fixtures to support reliability stress testing.
• Work with cross-functional teams to fabricate and validate test setups.
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7. Reliability Analyses (Electronics & System Level)
Key Responsibilities
1. Lead technical teams in the implementation and maintenance of systems compliant with iso 13485 and mdd requirements.
2. Provide expertise on mdr regulations and guidelines to ensure product development and validation processes meet the necessary standards.
3. Collaborate with cross functional teams to align technical strategies with regulatory requirements.
4. Conduct audits and assessments to verify compliance with mdr, iso 13485, and mdd requirements.
5. Develop and implement strategies to address technical challenges and optimize processes in compliance with medical device regulations.
Skill Requirements
1. Proficiency in interpreting and applying mdr regulations, iso 13485 standards, and the medical device directive (mdd).
2. Strong technical leadership skills to guide teams in achieving compliance goals effectively.
3. Excellent communication skills to interact with stakeholders and convey technical requirements clearly.
4. Analytical thinking to assess complex technical issues and develop appropriate solutions.
5. Detail oriented approach to ensure accuracy and precision in compliance related tasks.
Other Requirements
1. Certification in Medical Device Regulations (MDR) or ISO 13485 is a plus.

📌 Senior Technical Lead MDR, ISO 13485, MDD (Bengaluru)
🏢 HCL Technologies
📍 Bengaluru