SENIOR DESIGN ASSURANCE ENGINEER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: October 14, 2024 - The Senior Design Assurance Engineer demonstrates excellent presentation and communication skills, fostering effective teamwork and collaboration. Proficient in managing individual and team tasks while providing direction, showcasing a strong understanding of design controls and risk management processes. Experienced in technical report writing and statistical software, with project management and problem-solving capabilities to drive successful product development initiatives.

Essential Hard and Soft Skills for a Standout Senior Design Assurance Engineer Resume
  • Design Control
  • Risk Management
  • Regulatory Compliance
  • Technical Report Writing
  • Statistical Analysis
  • Quality Assurance
  • Failure Mode and Effects Analysis
  • Prototyping
  • Design Verification and Validation
  • Microsoft Office Proficiency
  • Effective Communication
  • Team Collaboration
  • Problem Solving
  • Critical Thinking
  • Attention to Detail
  • Time Management
  • Adaptability
  • Leadership
  • Interpersonal Skills
  • Proactive Thinking

Summary of Senior Design Assurance Engineer Knowledge and Qualifications on Resume

1. BA in Quality Assurance with 8 Years of Experience

  • Excellent presentation, written and verbal communication skills, and interpersonal skills
  • Ability to work in a team environment.
  • Ability to define, organize, and manage individual and team tasks; provide direction to core and extended team members.
  • Ability to work proactively and independently.
  • Ability to define, organize, and manage individual and team tasks, provide direction to core and extended team members.
  • Strong understanding of design controls, risk management, and new product development processes.
  • Proficient in technical report writing and review.
  • Experience in statistical software packages (e.g. Minitab, Statistica, NCSS, etc.).
  • Proficiency in using Microsoft Office Applications required (MS Word, MS Excel, MS PowerPoint).
  • Project management and problem-solving skills

2. BA in Biomedical Engineering with 8 Years of Experience

  • Design Quality Assurance experience in a regulated medical device environment, specifically in a product development support role
  • Design and testing experience in electrical engineering and SW/hardware including Board level design, DSPs and FPGAs
  • Experience in responsibility for compliance with FDA QSR, MDD/MDR and ISO regulations
  • Experience in responsibility for medical device Design Verification and Validation activities
  • Experience in and responsibility for product and process risk analysis/FMEA, requirements writing, test method development and validation, statistical analysis of quantitative and qualitative data, verification & validation protocol/report writing and medical device design reviews.
  • Previous work experience in life science products and/or medical device fields 
  • Previous work experience with IEC standards including but not limited to IEC 61010, IEC 60601, IEC 62304
  • Proficient in computer skills such as MS office programs
  • Strong written and oral skills

3. BA in Mechanical Engineering with 7 Years of Experience

  • Experience in design assurance/quality assurance experience in a medical device or other highly regulated industry
  • Working knowledge of ISO and FDA design and development quality requirements.
  • Technical knowledge in development methodologies, design quality analysis, and project implementation.
  • Proficiency in assessing manufacturing quality requirements of new product concepts.
  • Technical knowledge in development methodologies, design, and project implementation, including but not limited to, GD&T & DOE
  • Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment
  • Strong organizational and management skills
  • Strong attention to detail

4. BA in Electrical Engineering with 6 Years of Experience

  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
  • Experienced with ISO 14970, Risk Management
  • Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
  • Working knowledge of verification and validation requirements for a regulated product
  • Working knowledge of requirements analysis, including development of testable and measurable specifications
  • Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
  • Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment
  • Strong problem-solving skills
  • Strong knowledge of Reverse Osmosis Systems

5. BA in Biomedical Engineering with 4 Years of Experience

  • Experience as a Reliability or Quality Engineer in a regulated design environment.
  • Prefer experience with medical device product development life cycle, including risk management and design verification & validation
  • Knowledge of FDA QSR, EU MDR, ISO 13485 Design Control Procedures and ISO 14971
  • Demonstrated ability to effectively work cross functionally with other departments including Product Development, Regulatory and Clinical.
  • Demonstrated problem-solving and troubleshooting skills.
  • Demonstrated interpersonal and communication skills.
  • Demonstrated a positive, energetic approach to teamwork.
  • Demonstrated ability to learn quickly and multi-task
  • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.

6. BA in Mechanical Engineering with 7 Years of Experience

  • Experience in the Quality Engineering, Design Assurance, and/or Sterilization
  • Strong analytical background
  • Strong working knowledge of the FDA Quality System Regulation, Medical Device Regulations, and ISO 13485, 10993, 11135, and 11137.
  • Demonstrated knowledge and proficiency in the application of ISO 14971 and other standards related to product design and development
  • Demonstrated project management skills
  • Understanding of sterilization methods, cycle validation and managing validation activities
  • Skilled in the application of statistical methods
  • Skilled in the application of analytical testing and methodologies
  • Moderate level of computer proficiency including MS Word, Excel, Project, database, and statistical applications software
  • High attention to detail, organization and accuracy

7. BA in Electrical Engineering with 6 Years of Experience

  • Overall medical device experience
  • Experience in quality assurance or engineering function
  • Expert knowledge of Design Control and Risk Management
  • Knowledge of Problem Solving methodologies and approaches
  • Experience with Quality Systems as outlined in CFR820/ ISO13485
  • Experience with leading CAPA investigations and developing effective corrective actions that utilize a risk based approach
  • Demonstrated technical expertise and leadership in quality
  • Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
  • Demonstrated use of Quality tools and methodologies
  • Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)