Tech 2 Mechanical Engineering
Tech 2 Mechanical Engineering
Posted on :
04-10-2024
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Job Description
Description:
This position is responsible for drug delivery systems or combination product test method development and validation with minimal supervision. The candidate will develop tests including but not limited to Design Characterization and Design Verification
PRIMARY DUTIES/RESPONSIBILITIES
Authors test methods test protocols test method validations and test reports with minimal supervision
Plans and performs experiments that support new product or technology feasibility testing.
Conducts testing as assigned applying appropriate test methods protocols specifications and equipment (includes product and/or equipment testing)
Adheres to ZebraSci Quality Systems including but not limited to; timely identification and notification of potential Quality Events (e.g. OOS Deviations CAPA ) and the subsequent forward processing and investigation of such events
Effectively communicates orally and written project progress and results within the Technology Development and operations team
Responsible to maintain the lab and storage areas in a clean and organized manner.
KNOWLEDGE AND SKILLS:
Knowledge of drugdevice combination products and/or medical devices
Knowledge of the operation of mechanical measurement equipment (e.g. Instron Zwick) vision systems (Keyence) and container closure integrity instrumentation
Experience with test method development and validations (MSA Gage R&R etc.) is desirable
Application of statistical and analytical methods such as Design of Experiments ANOVA analysis and statistical software (Minitab JMP etc.)
Knowledge of GLP cGMPs 21CFR820.30 ISO and ASTM procedures beneficial.
EDUCATION AND EXPERIENCE:
Bachelor s or Master s degree in Mechanical/Biomedical/Chemical or relevant engineering field plus relevant experience related to combination product or medical device development and/or testing:
15 years of experience with a BS
PRIMARY DUTIES/RESPONSIBILITIES
Authors test methods test protocols test method validations and test reports with minimal supervision
Plans and performs experiments that support new product or technology feasibility testing.
Conducts testing as assigned applying appropriate test methods protocols specifications and equipment (includes product and/or equipment testing)
Adheres to ZebraSci Quality Systems including but not limited to; timely identification and notification of potential Quality Events (e.g. OOS Deviations CAPA ) and the subsequent forward processing and investigation of such events
Effectively communicates orally and written project progress and results within the Technology Development and operations team
Responsible to maintain the lab and storage areas in a clean and organized manner.
KNOWLEDGE AND SKILLS:
Knowledge of drugdevice combination products and/or medical devices
Knowledge of the operation of mechanical measurement equipment (e.g. Instron Zwick) vision systems (Keyence) and container closure integrity instrumentation
Experience with test method development and validations (MSA Gage R&R etc.) is desirable
Application of statistical and analytical methods such as Design of Experiments ANOVA analysis and statistical software (Minitab JMP etc.)
Knowledge of GLP cGMPs 21CFR820.30 ISO and ASTM procedures beneficial.
EDUCATION AND EXPERIENCE:
Bachelor s or Master s degree in Mechanical/Biomedical/Chemical or relevant engineering field plus relevant experience related to combination product or medical device development and/or testing:
15 years of experience with a BS
Additional Details
- Exempt/NonExempt Status : NonExempt
- Industry Title : Tech 2 Mechanical Engineering
- Job Group : 1
- Project Name : (No Value)
- Contract to hire position : Unknown
- Screening Requirements : N/A
Employment Type
Full Time
Key Skills
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