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Tier-1 brand, Bangalore metro and mid-level experience increase competition, though medical-device specialization narrows the pool.
Medical-device regulatory and IEC standard requirements limit cross-industry transferability.
Explicit 5–7 year requirement and mandatory IEC 62304/regulatory experience make shortlisting highly strict.
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Lead implementation of process validation plans to facilitate new product introductions using statistical tools.
Manage the end-to-end design control process including design input validation, verification, validation, and transfer ensuring regulatory compliance.
Drive quality improvements and risk management across product lifecycle including post-market surveillance and root cause analysis of design deficiencies.
Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
5-7 years of experience in Quality Engineering, Safety Engineering, or R&D Engineering with preference for hardware and software product experience.
Experience with IEC 62304/82304 standards mandatory.
Role requires full-time onsite presence at company facilities at least 3 days per week.
Experience in medical device R&D, quality, or safety in a regulated environment (5-8 years preferred).
Proficient with quality management for hardware and software design, including design verification, validation, and risk assessment.
Skilled in applying data analysis, root cause analysis, CAPA methodologies, and continuous improvement techniques to complex quality issues.