Medical Device Engineering Support Specialist

Gaithersburg, Maryland 20878

Post Date: 03/22/2018 Job ID: 28241 Industry: Other Area(s)

Medical Device Engineering Support Specialist

The candidate will be a part of Drug Delivery and Device Development group working on combination device characterization and functionality testing and studies.

The candidate must be  able to design, develop and execute DOE experiments for primary container and device characterization. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOPs, protocols, and reports with minimum supervision. Present findings at internal meetings, prepare manuscripts and patent applications. Be able to conceptualize, design, and develop novel solutions utilizing a combination of mechanical and electrical engineering techniques and knowledge. Meet and complete assigned task in timely and efficient manners. Innovate, develop and evaluate primary container and device characterization techniques and technologies as they relate to combination product development requirements. Perform test method development, qualification and method transfer to GMP testing group in support of device verification & validation testing. Be an accomplished user of device engineering and testing software/tool/equipment such as the Rap ID layer explorer, INSTRON tensile test machine, confocal and/or light microscopy, Cognex / Keyence vision system, Solidworks, Minitab, Labview, Matlab and etc. Develop process descriptions to standardize testing procedures across analysts. Establish and maintain a close working relationship with internal departments and stakeholders. Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. 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. Ensure work complies with the MedImmune EH & S code of practice. Assist where appropriate in the training of new members of the FS/DDDD group, particularly with the Instron test system. Position Requirements: Prior experience with medical device and/or combination product design and development. Experience with Solidworks, Instron, Minitab, 3D printer, and microscopy Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus. Prior experience designing and/or developing electro-mechanical devices is a plus. Knowledge of medical / combination device verification & validation is a plus. 

Required:

1 - Engineering degree (B.S. or M.S. degree in Mechanical/Biomedical/Electrical/ Materials/Chemical Engineering or related field)

2 - Hands-on experience with INSTRON and Solidworks (at least 1 year)

3 - Medical device experience in a Pharma setting

4 - Prior 21CFR experience, Part 4 or A20 (medical device)

5 - GDP experience (good documentation practices)

Prior industry experience in pharmaceutical/biotech/medical or drug delivery device or relevant Academic Lab a plus.

Good communication skills and strong interpersonal skills are essential.

Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment are an integral part of this position.

Strong work habits and commitment to the position are highly valued.

Problem solving, innovation and creativity are also fundamental qualities for this role.

Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and supervision.
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