Senior Design Quality Engineer/ Design Quality Engineer

HealthMinds Consulting Pvt. Ltd; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

HealthMinds Consulting Pvt. Ltd in Bengaluru seeks a Senior Design Quality Engineer to oversee quality plans across product lifecycle and ensure design controls are met.

The role requires strong knowledge of medical device quality standards, experience with V&V, FMEA, and risk management, and the ability to drive design for quality. You’ll collaborate with cross-functional teams to deliver compliant, reliable medical devices.

Qualifications

• Bachelor's or Master's in Mechanical/Electrical/Electronic or related engineering.
• 5-7 years (or 3+ years with Master's) in medical device industry.
• Experience with medical device quality practices is preferred.

Responsibilities

• Ensures quality plans cover all product life-cycle stages.
• Oversees execution of quality plan, risk management, and design activities.
• Validates design inputs: usability, reliability, performance, manufacturability, security, privacy.
• Performs product quality assessment and post-market analysis.
• Reports field quality performance and initiates field actions as needed.
• Ensures compliance in design reviews, verification, validation, and transfer.
• Applies design for quality practices (FMEA, robust design, V&V, RCA).

Skills

Quality management

V&V

FMEA

Risk management

Documentation

Education

Bachelor's in Engineering

Master's in Engineering

Job description

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' 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.
• Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Understand the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.