DESIGN QUALITY ENGINEER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Mai 22, 2025 - The Design Quality Engineer excels in specialized technical procedures relevant to biomedical engineering, with comprehensive knowledge of FDA/GMP, CMDR, MDD, and ISO 13485 standards. Proficient in manufacturing processes, including inspection technologies and clean room operations, and well-versed in Microsoft Office applications. Effectively collaborates within team environments, ensuring compliance with Design Control Regulations and managing diverse aspects of hardware, software, and bioassay systems.

Essential Hard and Soft Skills for a Standout Design Quality Engineer Resume
  • Statistical Analysis
  • Risk Management
  • Quality System Knowledge
  • CAD Software Proficiency
  • Process Validation
  • FMEA Development
  • Biomedical Engineering Principles
  • Inspection Techniques
  • Data Analysis Software Proficiency
  • Regulatory Compliance.
  • Communication
  • Problem-Solving
  • Attention to Detail
  • Teamwork
  • Leadership
  • Adaptability
  • Critical Thinking
  • Time Management
  • Project Management
  • Persuasive Negotiating.

Summary of Design Quality Engineer Knowledge and Qualifications on Resume

1. BS in Mechanical Engineering with 4 Years of Experience

  • Capability to carry out specialized technical/trade/craft procedures. 
  • Speaking skills to discuss/explain semi-complex information or writing skills to communicated standard matters or procedures.
  • Experience in biomedical engineering standards and concepts. 
  • Knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
  • Knowledge of manufacturing processes (and associated tools, instruments and test equipment) to include inspection, machine shop technology, polish/grind and clean room technology.
  • Knowledge of Microsoft Word, or equivalent word processing software, Excel, or equivalent spreadsheet software.
  • Work effectively in a team environment
  • Working knowledge of Design Control Regulations and experience with hardware, software, and bioassay systems.

2. BS in Biomedical Engineering with 5 Years of Experience

  • Display working knowledge and provide guidance to design change teams in the area of usability/human factors engineering priniciples including standards (IEC 62366) and FDA guidance for compliance.
  • Able to collect analyze and interpret data will be an integral part of the daily responsibilities.
  • Able to utilize data to make driven decision and recommendations.
  • Ability to work as a member of a scrum team or in a supporting function, solve problems, meet commitments, and ensure quality and require some direction from supervisors.
  • Experience both within the field of Design Quality Assurance and testing.
  • Advanced level of technical software proficiency
  • Advanced Quality Systems knowledge 
  • Knowledge of ISO134971 version 2019 CFR820, IVDD/IVDR, ISO13485

3. BS in Industrial Engineering with 5 Years of Experience

  • Experience in a QA function (Medical Device industry preferred)
  • In depth work experience within the medical device industry with knowledge of FDA, Health Canada, EU MDR, PMDA, SFDA medical device regulations, standards and guidance documents (QSR 21 CFR 820, CMDR, MDD and ISO 13485, ,IEC 60601, ISO 10993, ISO14971,)
  • Experience and aptitude in Design of Experiments desirable
  • Ability to effectively communicate both verbally and in writing and to apply critical thinking in problem identification and resolution.
  • Prior experience in a multi-site development environment.
  • Prior experience in compliance management within a rapid-growth, dynamic organization.
  • Working knowledge of FDA, USDA, and applicable non-regulations pertaining to medical or pharmaceutical manufacturing
  • PM experience 

4. BS in Chemical Engineering with 6 Years of Experience

  • Fluent in English both spoken and written.
  • Background in Design / Class A Surface modeling / Perceived or Product Quality 
  • Experience in an Automotive Engineering or Design environment
  • Technical background with a good understanding of tooling requirements for sheet metal and plastic parts.
  • Experience using ICEM Surf / Alias 
  • Knowledge VRED and CATIA V5 experience 
  • PDM System Team Center experience
  • A good understanding of homologation and legal requirements for Vehicle Design
  • Ability to work in cross-functional teams and lead Design Quality activities on several Projects
  • Strong interest in automotive technology.

5. BS in Biomedical Engineering with 3 Years of Experience

  • Experience in regulated design environments, such as medical device development, FDA, or ISO-registered work experience
  • Experience with Risk Management ISO 149713. 
  • Experience with Quality Engineering, Product Development, or Design Verification engineering
  • Project Management Skills
  • Ability to communicate effectively, both verbally and in writing, to technical and non-technical audiences.
  • Must have the ability to use tact, good judgment and initiative.
  • Must have demonstrated leadership qualities.
  • Must have excellent oral, and written communication skills.
  • Ability to work under pressure with a minimum of supervision.
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