Device Engineer I/ II - Gaithersburg, MD | Biospace
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Device Engineer I/ II

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
R-006904
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, Maryland, United States
Job reference: R-006904

Posted date: May. 03, 2017

                                                     
                           


 

   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 I/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 Responsibilities  

 

   The candidate for this position will be part of Medimmune’s Drug Delivery and Device Development group working on combination product development, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations.  

   Under minimal supervision, the candidate will manage and accomplish assigned projects in a timely fashion and to agreed quality standards. Apply knowledge and expertise to take responsibility for ensuring appropriate and robust test methods are developed and qualified in support of device development projects. Proactive in proposing innovative ideas and solving complex problems.  

   Establish and champion best practices for test method qualification, ISO functionality device testing, and participate in general assessment for biocompatibility assessment.  

   Identify, evaluate, and develop solutions for digital connectivity integration (internal and external) within mechanical and electro-mechanical delivery systems.  

   Hands on development and qualification of device test methods, fixtures, and custom accessories (which may be electromechanical in nature). Author technical reports and process descriptions as required. Be an accomplished user of device testing instruments such as INSTRON tensile test machine, Mitutoyo QVX302 optical measurement system, Lansmont transportation simulator, and other engineering tools.  Develop process descriptions to standardize testing procedures.  

   Be able to design, develop and execute DOE experiments for device characterization. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOPs, protocols, and reports with minimum supervision. Assess and report data with a clear understanding of its reliability interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated.Present findings at internal/external meetings, prepare manuscripts and patent applications.  

   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, and etc.).  

 

   Manage the transfer of developed test methods to internal and external quality control testing sites. Plan and manage device DV and stability testing.  

   Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/ASTM/MDD/GMP/GLP, 21CRF820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Prepare formal reports and contributions to regulatory documentation.  

   Keep the various process description documents up to date and contribute to the tech transfer documentation as required. Present data at the team and Department meetings as required.  Maintain and contribute to Quality Systems 21 CFR820.30 and ISO 13485 within the group to ensure consistency and conformance with GxP working practices  

Requirements

   Essential Requirements  

   Education:  BS, MS, or PhD degree in Mechanical/Electrical/Biomedical/Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field.  

   Experience:    

 

   For Device Engineer I: PhD 0-3 years, MS 2-5 years, and BS 5-7 years of relevant experience.  

 

   For Device Engineer II: PhD 3-5 years, MS 5-7 years, and BS 7-10 years of relevant experience.  

   Knowledge  

 
       
  •      Requires understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry, and is expected to demonstrate up to date technical knowledge.    
  •    
  •      Knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.).    
  •    
  •      Prior experience with electro-mechanical drug delivery and/or medical device system development a plus.    
  •  

   Special Skill/Abilities  

 

   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, a hands on scientific approach, innovation and creativity are also fundamental qualities for success in this role.  

   Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and guidance. Candidate is expected to be pro-active in identifying critical activities and prioritizing project tasks appropriately.  

   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.  

   *LI-MEDI  

 

~BSP