Senior Design Quality Engineer/ Design Quality Engineer

HealthMinds; Bengaluru; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

HealthMinds is seeking a Senior Design Quality Engineer in Bengaluru to lead quality planning across the product lifecycle. You will oversee risk management and design-related activities, validating inputs for usability, reliability, performance, and security.

You will analyze post-market quality data and coordinate field actions when needed, ensuring compliance in design reviews and transfers while applying robust quality practices like FMEA and RCA.

Qualifications

• Bachelor's degree in engineering with related experience in medical devices.
• Experience with design controls and regulatory requirements (e.g., ISO 13485, 21 CFR Part 820).
• Strong knowledge of risk management and FMEA/FTA methodologies.
• Familiarity with Design Verification/Validation processes and usability considerations.
• Ability to develop and implement quality programs and analyses.

Responsibilities

• Ensures quality plans cover all life-cycle stages of the product and support quality plan design.
• Oversees execution of the Quality Plan, risk management activities, and design-related tasks.
• Validates design inputs including usability, reliability, performance, and security.
• Analyzes post-market product quality and feeds insights back to manufacturing and design teams.
• Monitors compliance during design reviews, design verification/validation, and transfer.
• Applies design-for-quality and reliability best practices (FMEA, robustness, RCA).

Skills

Regulatory knowledge

Design controls

Risk management

FMEA/FTA

Verification & Validation

Statistical methods

Education

Bachelor's Engineering degree

Engineering Degree or equivalent experience in medical devices

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, VV, RCA, Problem-solving).

Qualifications

• Bachelors Engineering degree with 5-7 years of related experience or Masters 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.