Location:Gaithersburg, United StatesJob reference:
Sep. 23, 2016
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 Medical Device Engineer 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
You will be responsible for combination product development involving parenteral injection devices delivering biologics and peptides. You will support the technical and industrial development of mechanical and electro-mechanical medical devices to ensure timely delivery to the market. You will work closely with team members on dedicated tasks to create detailed engineering designs, develop test methods, conduct design verification studies, and support regulatory submissions of combination products.
You will have significant interactions with biopharmaceutical development functions particularly working with project teams in Medimmune, as well as collaborating with AstraZeneca's manufacturing, regulatory and quality organizations, and external device development partners.
* Bachelor's in mechanical engineering, biomedical engineering, materials engineering or related engineering fields with Higher degrees in the related engineering fields is an asset, and five plus years of device development/manufacturing experience in a regulated industrial environment
* Ability to apply patient-centric methodologies and demonstrate engineering competence in the field of injection device technology
* Fundamental understanding of the user needs in the targeted therapeutic population, translating the voice of customer into technical requirements, and creating engineering design features to deliver the best user experience
* Collaborating with device partners to develop design prototypes, testing fixtures, jigs, and conduct formative human factors studies
* Establishing and championing best practices for test method validation, ISO functionality device testing, participate in general assessment for biocompatibility assessment as well as extractable /leachable
* Ability to manage and execute the component and subassembly testing and approval process with knowledge in CAD/SolidWorks, transportation as well as stability and aging
* Experience interfacing with Formulation Sciences to facilitate business needs for primary containers, fill and finish with Medimmune drug assets for design verification
* Ability to develop, maintain and satisfy quality, regulatory requirements relating to all aspects of design control documentation
* Must be self-motivated and able to quickly develop the leadership and business acumen to work in a matrix environment effectively
* Product development experience in the areas of biologics delivery and devices including auto injectors, pre-filled syringe, pen injectors and large volume bolus injectors
* Ability to be a contributing member to multiple project teams supporting the device platform team delivering new platform devices
* Excellent technical writing and verbal communication skills
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