Senior Design Quality Engineer/ Design Quality Engineer

Healthminds; Bengaluru; On-site; INR 900,000 - 1,400,000; Full time

Job summary

HealthMinds Consulting Private Limited in Bengaluru seeks a Senior Design Quality Engineer to oversee design quality plans across the product lifecycle. You will validate inputs, participate in design reviews, and drive risk management activities to ensure compliance with regulatory standards for medical devices.

You will apply FMEA, V&V, RCA, and robust design practices, coordinate with design and manufacturing teams, and help transfer designs to production while ensuring usability,

Qualifications

• Knowledge of global medical device regulations and standards.
• Experience with design verification and validation activities.
• Familiarity with risk management and FMEA processes.

Responsibilities

• Ensure quality plans cover all stages of product life cycle.
• Oversee design-related activities and risk management.
• Validate design inputs like usability, reliability, and safety.
• Support post-market quality analysis and field feedback.
• Apply design for quality practices (FMEA, V&V, RCA).

Skills

Regulatory knowledge

Quality systems

FMEA

RCA

V&V

Risk management

Statistical methods

Education

Bachelor’s Engineering (Mechanical/Electrical/Electronic)

Master’s degree in related field

Job description

HealthMinds Consulting Private Limited | Full time

Senior Design Quality Engineer/ Design Quality Engineer

• 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.
• 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.