Device Engineer
A$ A' A' ?Position - Device Engineer Location - Gaithersburg MD Contract - 12 Months with a possibility of extension
Job Description:
We are seeking a device engineer to join the Device Functionality and Safety team.
The position is in the Device Functionality and Safety group (Device Lab) within the Device Department.
Device Development provides combination product expertise to the development of drug-delivery parenteral for the expanding pipeline.
Desired Skills:
Medical Device Development, Combination ProductsDesign ControlsValidation/VerificationEducation/Skills/
Experience:
B.
S.
+4 years of relevant experienceM.
S +2 years of relevant experienceMain Duties &
Responsibilities:
The candidate will be responsible for the following activities:
Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.
Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision.
Deliver timely, high quality data and interpretations to drive key scientific solutions.
Is expected to be familiar with medical device development and preferably combination devices.
Establish and maintain a close working relationship with equipment vendors and contribute to oversite of external collaboration partners.
Liaise effectively with internal departments (Quality, Regulatory, Operations, etc ).
Be proficient in 3D design and modeling fixtures using Solid works.
Be a skilled user of device engineering and testing software/tool/equipment such as the tensile test machine (INSTRON), confocal and/or light microscopy, Minitab, and etc.
Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.
Ensure that work is performed in accordance with appropriate quality and compliance standards, eg - USP/PharmEur, ISO /MDD/GMP/GLP, 21CRF Part 4 & 820.
30 and applicable safety requirements.
Prepare and maintain documentation and formal reports in accordance with these standards.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Description:
We are seeking a device engineer to join the Device Functionality and Safety team.
The position is in the Device Functionality and Safety group (Device Lab) within the Device Department.
Device Development provides combination product expertise to the development of drug-delivery parenteral for the expanding pipeline.
Desired Skills:
Medical Device Development, Combination ProductsDesign ControlsValidation/VerificationEducation/Skills/
Experience:
B.
S.
+4 years of relevant experienceM.
S +2 years of relevant experienceMain Duties &
Responsibilities:
The candidate will be responsible for the following activities:
Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.
Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision.
Deliver timely, high quality data and interpretations to drive key scientific solutions.
Is expected to be familiar with medical device development and preferably combination devices.
Establish and maintain a close working relationship with equipment vendors and contribute to oversite of external collaboration partners.
Liaise effectively with internal departments (Quality, Regulatory, Operations, etc ).
Be proficient in 3D design and modeling fixtures using Solid works.
Be a skilled user of device engineering and testing software/tool/equipment such as the tensile test machine (INSTRON), confocal and/or light microscopy, Minitab, and etc.
Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.
Ensure that work is performed in accordance with appropriate quality and compliance standards, eg - USP/PharmEur, ISO /MDD/GMP/GLP, 21CRF Part 4 & 820.
30 and applicable safety requirements.
Prepare and maintain documentation and formal reports in accordance with these standards.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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