Design Quality Engineer

Role & 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).

Preferred candidate profile

• 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.

Must have:

• Bachelors 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