Essential Duties and Responsibilities:
- Analyze and interpret customer blueprints and perform required inspections on said blueprints
- Perform Gage R & R to analyze and identify error sources contributing to uncertainty of measurement results to determine reliability of measurement device, fixture, process etc.
- Create, redesign or adjust measurement method for existing product as needed to minimize error
- Deploy inspection methods used during validation to be used by in-process inspectors during Performance Qualification (PQ runs or other) and post-validation production runs
- Develop new inspection files that contain pictures, inspection methods and inspection instructions as needed, to be used during in-process inspections and assist in modifying/editing existing inspection files
- Provide engineering team with First Article Inspection reports, Operational Qualification (OQ) Inspection reports and Performance Qualification (PQ) Inspection reports or other as required.
- Provide engineering team with measurement results and coinciding analysis of Design of Experiments (DOE) parts
- Design and implement new inspection fixtures
- Perform other duties as assigned
Education, Training, Skills and Experience Requirements:
- High School Diploma or equivalent
- Must have good English written and verbal communication skills
- Ability to use basic hand measurement tools (calipers, micrometers, gauge pins, etc.) is required
- Experience with optical/Vision and automated/CMM systems is desired
- Experience with blueprint reading and knowledge of Geometric Dimensioning and Tolerancing (GD&T) is desired.
- Experience with software such as, but not limited to Minitab, Solidworks, Inspection Xpert (or equivalent), IQMS, PC-DMIS (or equivalent), InSpec (or equivalent) and Microsoft Excel is desired
- Three years’ experience in exact or related position preferred
- Knowledge of ISO 13485:2003 & 9001:2008 and Good Documentation Practices
- Experience with medical devices and cleanroom environments desired
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time.
This position will require you to submit to and pass a drug test and/or background check. EirMed, LLC will comply with all applicable federal and state laws governing the use of such background checks and drug tests.
We offer a competitive salary, benefits, and the opportunity for career growth to the right individual.