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The Role
Develops and oversees product quality plans across the medical device lifecycle. Leads risk management, design quality reviews, verification and validation, design transfer, post-market quality analysis, and regulatory compliance. Applies FMEA, robust design, root cause analysis, statistical methods, and reliability practices. Evaluates design inputs including usability, performance, manufacturability, security, privacy, and serviceability, while reporting field quality performance and supporting corrective actions.
Summary Generated by Built In
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 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.
Skills Required
- Bachelor's degree in Mechanical, Electrical, Electronic, or equivalent Engineering, with 5–7 years of related experience
- Master's degree in Engineering, with 3+ years of related experience
- Engineering degree or equivalent experience in the medical device industry
- 3+ years of experience with a medical device company
- Knowledge of global medical device or consumer product regulations, requirements, and standards, including 21 CFR Part 820, ISO 13485, ISO 14971, MEDDEV, and EU MDR
- Experience or understanding of software or hardware development, verification and validation, risk management, root cause analysis, requirements management, design, and usability
- Understanding of sample size determination and statistical methods
- Understanding of safety risk management, FMEA, and Fault Tree Analysis
- Understanding of quality system development, documentation, and implementation against domestic and international standards
- Understanding of audit planning, preparation, execution, reporting, and follow-up
- Ability to develop and implement quality programs involving tracking, analysis, reporting, and problem-solving
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The Company
What We Do
HealthMinds Consulting Private Limited is a Bengaluru-based healthcare advisory and medical communications company. It supports healthcare and life-sciences organizations through health data analytics, academic and commercial research, public health consulting, scientific and medical writing, regulatory documentation, branding, and digital CRO solutions. Its work serves pharmaceutical, biotech, medtech, academic, and healthcare clients, translating complex scientific information into accurate, actionable content and strategies for professionals, patients, regulators, and broader markets.
