DESIGN ASSURANCE ENGINEER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: October 14, 2024 - The Design Assurance Engineer brings experience in medical device and technology development, with a strong understanding of EU MDR requirements and regulations. Proficient in engineering principles, design controls, and risk management, capable of analyzing complex information independently. Demonstrates strong verbal and written communication skills, alongside the ability to apply statistical methods effectively.

Essential Hard and Soft Skills for a Standout Design Assurance Engineer Resume
  • Regulatory Compliance
  • Risk Management
  • Design Control
  • Quality Assurance
  • Statistical Analysis
  • Technical Documentation
  • Usability Engineering
  • FDA Regulations
  • ISO Standards
  • Medical Device Development.
  • Strong Communication
  • Problem-Solving
  • Attention to Detail
  • Critical Thinking
  • Team Collaboration
  • Adaptability
  • Time Management
  • Initiative
  • Conflict Resolution
  • Analytical Thinking.

Summary of Design Assurance Engineer Knowledge and Qualifications on Resume

1. BA in Biomedical Engineering with 5 years of Experience.

  • Experience in medical device and/or technology development.
  • Working knowledge of EU MDR Requirements and Regulations for medical devices
  • Must be able to work independently with minimal supervision
  • Understanding of engineering principles and best practices
  • Strong communication skills both verbal and written
  • Ability to analyze and interpret complex information
  • Understanding of and ability to apply requirements found in Design Controls (21 CFR 820.30), Risk Management (ISO 14971), Usability engineering (IEC 62366-1)
  • Understanding of and ability to apply statistical methods such as determining process capability, hypothesis tests, and determining sample sizes.

2. BS in Quality Assurance with 3 years of Experience.

  • Experience in Quality Engineering. 
  • Hand-on experience in ISO 13485, MDD, and FDA QSR compliant Quality Systems with a medical device manufacturing company. 
  • Experience with Class II and/or III sterile devices 
  • Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity.
  • Experience with metal fabricated components and/or plastic injection molded components.
  • Experience in sterilization validations (radiation) and biocompatibility testing of products
  • Experience with IEC 60601 and/or IEC 62304 requirements 
  • Strong written, oral, and interpersonal skills.
  • Strong analytical skills, problem solving techniques and statistical application experience.
  • Extensive knowledge in the areas of Design Controls, Design Validation & Verification, Risk Management, Process Validation

3. BS in Mechanical Engineering with 5 years of Experience.

  • Experience in a Medical Device manufacturing/product development environment
  • Prior Medical Device Industry experience
  • Working knowledge of FDA QSR's, ISO 13485, and ISO 14971 requirements
  • Demonstrated use of Quality tools/methodologies
  • Experience/knowledge with product/process verifications/validations
  • Experience with DFMEA's, PFMEA's, and Risk Management
  • Problem solver with the knowledge of problem-solving tools, capable of facilitating the problem-solving process
  • Must possess good project management skills and initiative in taking on and completing projects
  • Must possess good verbal and written communication skills
  • Must be able to manage and prioritize multiple projects/objectives
  • Experience in a highly regulated industry in early phase development.
  • Program or project management experience.
  • A proven track record of delivering results.