Engineering Support Specialist

Company: Alpha Consulting
Location: Gaithersburg
Posted on: November 26, 2022

Job Description:

*ENGINEERING SUPPORT SPECIALIST**GAITHERSBURG, MD**Required Skills: * - B.S. +4 years of relevant experience. - M.S +2 years of relevant experience. - Medical device design - Design Controls. - Combination products. - Regulatory filing of pharmaceutical products. - Mechanical testing. - 3D model and rapid prototyping.*Project Description: * - 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 Solidworks. - 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. - Develop process descriptions to standardize testing procedures across analysts. - Innovate, develop, and evaluate device characterization techniques and technologies as they relate to device development requirements. - Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing. - Establish and foster a strong collaborative working relationship with internal departments and external vendors/suppliers. - Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. - 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.This 12+ month position starts ASAP.ALPHA'S REQUIREMENT #22-03094MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEEJob Types: Full-time, ContractBenefits:* 401(k)* Dental insurance* Health insurance* Health savings account* Referral program* Vision insuranceSchedule:* Weekend availabilityWork Location: One location

Keywords: Alpha Consulting, Washington DC , Engineering Support Specialist, Other , Gaithersburg, DC