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18 Aug 2021

Temporary Engineering Support Specialist (21-24754)

iris.chen@axelon.com – Posted by iris.chen@axelon.com Gaithersburg, Maryland, United States

Job Description

Engineering Support Specialist
Gaithersburg, MD
3+ Month Contract

Main Duties and Responsibilities:
• The successful candidate will serve as a core team member of cross-functional combination product pilot line team responsible for building design verification samples.
• He/she will be responsible for the technical aspects and implementation of a pilot line that builds new combination products including fill/finish and assemble/pack/label processes.
• He/she will complete material handling and process development and assemble builds of design verification samples
• He/she will author and review appropriate documentation for Design Verification sample builds are completed with traceability and quality approval
• He/she will work on complex and technically demanding process development where analysis of data may require an evaluation of multiple variables
• He/she will work in a collaborative matrix structure and interact with co-workers across different functional groups within research and development, regulatory affairs, quality and operations
• He/she will be able to perform process risk assessments

Essential Requirements Process/Device Engineer:

Education and Experience: BS or equivalent in Mechanical, Biomedical or related engineering background with at least 5 years relevant industry experience, MS or equivalent with at least 2 years relevant experience

Relevant Experience:
The candidate must have background in Medical Device and/or drug-device combination product development and be familiar with US and EU regulations. Must have technical experience with common tools and methods used for process development, such as DOE, pFMEA, equipment qualification, process validation and production batch records as examples. Candidate must have experience working in cross-functional matrix teams.

Other Requirements:
• The ability to author and follow SOPs, policies, and regulations
• Great teamwork and communication skills, both oral and written, are critical. Good prioritization, time management, and organizational skills are required.
• Experience writing technical documents such as procedures and reports

Desirable Skills and Experience:
• Experienced in Solidworks 3D CAD
• Understanding of other disciplines within biological process development and research
• Experience using statistical modeling and DoE
• Experience in commonly used manufacturing methods, such as fixture development, injection molding and automated assembly concepts

How to Apply

Please share Resumes to Iris.chen@axelon.com to apply.

Job Types: Temporary.

Job expires in 49 days.

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