Perform verification testing to ensure products and processes meet internal and external quality requirements that are in compliance with ISO 13485 Section 7.3 and FDA Title 21 Part 820.30.
Essential Duties and Responsibilities:
· Discuss changes in design, method of manufacture and assembly, and drafting techniques and procedures with engineering staff and coordinate corrections.
· Review project instructions and blueprints to ascertain test specifications, procedures, and objectives, and test nature of technical problems such as redesign.
· Perform engineering tests including test setup and tear down.
· Analyze test results in relation to design or rated specifications and test objectives and modify or adjust equipment to meet specifications.
· Write technical engineering test reports and submit reports of test results to engineering department and recommend design or material changes.
· Record test procedures and results, numerical and graphical data, and recommendations for changes in product or test methods.
· Setup and conduct tests of complete units and components under operational conditions to investigate proposals for improving equipment performance.
· Setup prototype and test apparatus and operator test controlling equipment to observe and record prototype test results.
· Generate progress reports and other engineering documentation as required.
· Complete all documentation per ISO 13485 and FDA requirements.
· All other duties as assigned.
Knowledge, Skills & Competencies:
· 1+ year in a test engineering environment preferred.
· Knowledge of the practical application of engineering and technology.
· Knowledge of raw materials, production processes, and quality control.
- Experience is ISO/FDA environment preferred.
- Ability to read and interpret detailed blueprints.
- Ability to learn the company quality system, as well as contractual quality requirements that vary by customer.
- Proficient in the use of a computer in a Windows environment, and proficient in Microsoft Excel.
- Proficient in math, including the ability to add, subtract, multiply and divide.
- Excellent manual dexterity, hand/eye coordination.
- Ability to be highly accurate with a high attention to detail.
- Ability to troubleshoot and problem solve issues.
- Ability to read and comprehend work instructions.
- Ability to repeat the same physical and mental activities over and over.
- Ability to maintain a sense of urgency, handle stressful situations, multitask and ability to prioritize work.
- Ability to work in a team environment as well as autonomously.
- Ability to communicate and interact effectively, professionally and constructively.
- Technical writing experience required.