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Works proficiently with precision dimensional measurement equipment, electronic measurement/test equipment, pressure transducers, flow meters, chart recorders, meters, and tensile testers.
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Follows released QMS SOPs and procedures, and work instructions to conduct daily work.
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Performs incoming inspection of raw materials, precision machine parts, printed circuit boards (PCBAs), sub-assemblies, and finished assemblies.
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Performs final physical/visual inspection of finished products.
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Conducts final product release for sterile lots.
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Sets up and operates routine experiments and tests using the appropriate related equipment with minimal supervision.
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Sets up and operates routine experiments for process validation and product verification using approved protocols and methods with supervision.
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Controls non-conforming material throughout the product lifecycle.
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Coordinates with other departments to prioritize inspections as appropriate.
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Verifies calibration and maintenance status of production equipment at time of use.
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Coordinates calibration of all portable and fixed measurement instruments and instrumentation.
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Supports and assists in the development of lean thinking programs and participates in the implementation of these programs throughout the facility as required.
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Documents inspection data in a clear and legible fashion.
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Works with other departments to resolve routine issues found during inspection tasks.
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Identifies procedural deviations and supports systematic problem solving and investigations.
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Adheres to, documents and archives work in accordance with Good Documentation Practices (GDP).
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Performs all job duties and responsibilities in a compliant and ethical manner, and in accordance with all applicable laws, regulations and industry codes.
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Acts as a positive force to drive teamwork, collaboration and continuous improvement by maintaining a positive, can-do attitude and drive for excellence.
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Maintains good attendance and on-time record.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.
- High School Diploma or General Education Diploma (GED).
- 1+ years of electro-mechanical inspection experience (calipers, micrometers, height gauge, tensile testing, peel testing, Instron or MTS equipment or equivalent).
- Skilled at following procedures and work instructions written in English and the ability to understand and execute from established written instructions.
- Ability to interpret electronic schematics, wiring diagrams, and mechanical drawings
- Knowledge of inspection/sampling techniques and familiarity with ANSI/ASQZ1.4.
- Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required
- Ability to communicate effectively internally and externally.
- Attention to detail and ability to prioritize tasks
- Good organizational, time management and documentation skills
- Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation:
§ Sit/Stand, Walk, Squat, Kneel, crawl, push/pull, vision (depth perception, field of vision), hearing, eye/hand coordination
§ Work with manual and power tools
§ Ability to interact with / use of office equipment
§ Lift/carry up to 25 lbs
§ Ability to wear and tolerate required personal protective equipment (ie, for handling biohazards, for working in cleanroom) for duration of assigned tasks
Nice to Have
The following skills/experiences are preferred and may give you an edge over other candidates.
- Associate degree in a STEM discipline (science, technology, engineering and mathematics)
- Associate degree in Electronics Technology or related field
- 2 years of medical device QC or manufacturing experience
- Experience and expertise in electronics technology and troubleshooting
- IPC J-STD-001 (Requirements for Soldered Electrical & Electronic Assemblies), IPC-A-600 (Acceptability of Printed Boards), IPC-A-610 (Acceptability for Electronic Assemblies) Certifications
- Knowledge of cleanroom gowning and work environment
About BrioHealth Solutions, Inc.
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enable chronic MCS therapy to be accessible to more patients across the globe.