Senior Design Quality Engineer/ Design Quality Engineer

Roles & Responsibilities
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and support Quality Plan design.
- Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system lifecycle.
- Validates key design inputs like usability, reliability, Performance, supportability, manufacturability, localizability, security, Privacy, serviceability, sustainability, and costs.
- Performs assessment of product quality performance and post-market product quality analysis.
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when enquired.
- Ensure compliance requirements are met during design reviews, design Verification, validation, and design transfer.
- Apply and Facilitate design for quality and reliability best practices (FMEA, robust design, V&V;, RCA,



Problem-solving).

Qualifications
- Bachelor’s Engineering degree with 5-7 years of related experience or Master’s degree with 3+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering
- Engineering Degree or equivalent experience in the medical device industry
- 3+ years’ experience with a medical device company preferably

Skill Set
- Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.).
- Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, and Usability.
- Understand Sample Size Determination and Statistical Methods, Safety Risk Management (i.e ISO 14971), and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis.
- Under

📌 Senior Design Quality Engineer/ Design Quality Engineer (Bengaluru)
🏢 Healthminds Consulting
📍 Bengaluru