Design Assurance Engineer Cover Letter

In response to your job posting for design assurance engineer, I am including this letter and my resume for your review.

In my previous role, I was responsible for training and development in problem solving methods, Failure Mode and Effect Analysis (FMEA) and Control Plans.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• ASQ or related quality certification is preferred
• Strong written and oral communications skills using English language
• Proactive and timely in execution of assigned tasks
• Experience as a contributing member of a team to take design from concept into production
• Regulatory compliance awareness such as FDA design controls CFR 820, ISO 14971, ISO 13485, IEC60601, IEC62304 and similar
• Minitab experience- Education/Training & Experience / Background
• Working knowledge of medical device regulations (FDA 21CFR80.820, ISO13485)
• Experience in an aerospace systems engineering environment

Please consider me for the design assurance engineer opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for a problem solving service to the refinery in the areas of process control and control systems.

Please consider my experience and qualifications for this position:

• Some contact with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel is essential
• Requires use of hands and arms to operate computer, printer, telephone, and develop drawings
• Allocating roles, responsibilities and production activities within the Project Design Team
• Knowledge of applicable ISO standards and FDA regulations
• Understanding of statistical analysis techniques and tools
• Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts)
• Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook
• Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems

I am excited to be applying for the position of design assurance engineer. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for standard training in quality systems and related areas such as APQP, BOS, Problem Solving, Statistical Process Control, Gage R&R, and error proofing.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience in requirement-based engineering / product development cycle (V&V cycle)
• Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485
• Demonstrated usage of Quality tools/methodologies
• Prior Descriptive Statistics and Hypothesis Testing
• Experience with process improvement tools
• Electrical Systems experience with knowledge of IEC 60601-1, 60601-1-2, and 62304 preferred
• Electrical Systems (development and sustaining)
• Experience with product or process design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding

In response to your job posting for design assurance engineer, I am including this letter and my resume for your review.

In my previous role, I was responsible for direct support to manufacturing and assist in process development and control, improvement efforts, failure analysis, and problem solving.

Please consider my qualifications and experience:

• Working knowledge of the underlying biomedical principles and understanding of how the products are used under clinical conditions
• Documentation of requirements and test plans utilizing tools such as DOORS
• Bachelor of Science in Software Engineer, Electrical Engineering, Biomedical Engineering or equivalent
• Proficient in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE
• Bachelor of Science in Engineering field
• Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, & ISO 11135 is necessary
• Proficiency in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM is a necessity
• Most often interacts with upstream marketing, quality assurance, research & development, regulatory, and manufacturing

I would like to submit my application for the design assurance engineer opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for expertise in the areas of statistical analysis & process control, lean & project management.

My experience is an excellent fit for the list of requirements in this job:

• Proficient in using Agile tools such as JIRA, Confluence, Test Rail)
• A good understanding and experience in Agile development, QA methodology and Scrum
• Seleniium/Appium knowledge or familiarity
• Certified Agile Technician (CAT)
• Strong understanding of quality policies, FDA Regulations and ISO Standards for medical device operations
• Strong knowledge of risk management, Quality, product/test method/process validations, and design controls
• Proficient with medical device product and process risk management regulations and standards under USFDA and EUMDD
• Technical skills in test method development and validation