Device Engineer

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Device Engineer (Associate Scientist I or Associate Scientist II) in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and ResponsibilitiesThe candidate will be a part of Medimmune Drug Delivery and Device Development group working on combination device characterization and functionality, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations.
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 device digital connectivity solutions utilizing a combination of mechanical and electrical engineering techniques and knowledge. Able to work and manage contract design vendors in ensuring project goals are met and in a timely manner.
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 external vendors/suppliers.
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.
Essential Requirements
Individual should have a B.S. or M.S. degree in Mechanical/Biomedical/Electrical/ Materials/Chemical Engineering or related field.
Associate Scientist I: (B.S. 2-5 years or M.S. / M.Eng. 0-3 years) experience in Industry (pharmaceutical/biotech/medical or drug delivery device) or Academic Lab.
Associate Scientist II: (B.S. 5-7 years or M.S. / M.Eng. 3-5 years) experience in Industry (pharmaceutical/biotech/medical or drug delivery device) or Academic Lab.
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.
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.
Desirable RequirementsPrior experience designing and/or developing electro-mechanical devices is a plus.
Knowledge of medical / combination device verification & validation is a plus.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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