Design Quality Engineer

Overview

Design Quality Engineer responsible for supporting Quality, Reliability, and Safety of medical devices across the product lifecycle.

What you'll do

• Support quality objectives tied to customer experience, complaint rate, and first past yield.
• Review reliability plans, quality requirements, and design-specification transfer to manufacturing and supply chain.
• Assess design/architecture suitability against quality criteria and review product deliverables.
• Apply Design for Quality & Reliability best practices including FMEAs, robust design, V&V, and root cause analysis.
• Drive improvements using post-market quality data such as complaints and quality notifications.
• Act as single point of contact for end-to-end design quality across project teams.

What you'll need

• 5+ years of industry experience with required healthcare/medical device experience.
• Experience validating usability, reliability, performance, supportability, manufacturability, safety, security, privacy, serviceability, sustainability, and costs.
• Bachelor’s or Master’s degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• ASQ CQE or CQM certification preferred.
• ISO 13485 auditor preferred.
• High-level English proficiency with strong writing skills.

Details

• Location: Pune.
• Office-based collaboration requires in-person work at least 3 days per week.
• Onsite roles require full-time presence in company facilities.