Senior Design Quality Engineer/ Design Quality Engineer
Summary
Oversee quality plans and risk management for medical devices, validating design inputs and ensuring compliance with global standards like ISO 13485 and 21 CFR Part 820.
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.