Senior Design Quality Engineer/ Design Quality Engineer

Healthminds Consulting; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

HealthMinds Consulting Private Limited is hiring a Senior Design Quality Engineer to oversee quality plans across the product lifecycle, validate design inputs, and drive post-market quality analysis. The role emphasizes risk management, V&V, and continuous improvement within a medical device context.

The engineer will ensure compliance during design reviews and transfer, applying robust design practices and problem-solving to maintain clinical and manufacturing standards.

Qualifications

• Applied knowledge of global medical device regulations and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR).
• Experience or understanding of software or hardware development, verification and validation, risk management, RCA, requirements management, design and usability.
• Understand sample size determination, statistical methods, safety risk management (ISO 14971), and FMEA.

Responsibilities

• Ensures quality plans cover all stages of the product lifecycle and supports Quality Plan design.
• Oversees execution of the Quality Plan, risk management activities, and all design-related activities.
• Validates design inputs like usability, reliability, performance, supportability, manufacturability, localizability, security, privacy, serviceability, sustainability, and costs.
• Performs assessment of product quality performance and post-market quality analysis.
• Uses post-market analytics to report on product quality performance and initiates field actions when required.
• Ensures compliance during design reviews, verification, validation, and design transfer.
• Applies design for quality and reliability best practices (FMEA, robust design, V&V, RCA, problem-solving).

Skills

Regulatory compliance

Quality management

FMEA

V&V

Risk assessment

Quality systems

Audits

Education

Bachelor's Engineering degree

Master's degree

Tools

ISO 13485

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.