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 Senior Device Engineer/Senior Scientist 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. Position Summary:
The candidate will be a part of MedImmune drug delivery and device development group responsible for combination product development involving parenteral injection devices delivering biologics and peptides. This position is in the platform device development team and will lead the development and implementation of state-of-the-art technologies to develop platform injection devices and provide expert advice for a diverse and complex pipeline of drug assets through entire portfolio ranging from clinical to commercial launch.
This role will lead technical and cross functional teams to ensure successful development and launch of mechanical and electro-mechanical medical devices. The Senior Device Engineer will lead combination product team to develop detailed engineering specifications, create device designs, oversee design verification/validation, and support regulatory submissions of combination products. This position will report to the Director of Platform Device Development.
This position requires 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. This individual must be independent and demonstrate the leadership and business acumen to work in a matrix environment effectively. Major Duties and Responsibilities:
Leads platform device projects as a technical team lead, fully responsible for all the device deliverables to support combination product development
- To provide expertise in patient-centric methodologies to understand targeted therapeutic populations' profile, conduct market research and human factors studies to collect user needs and identify unmet requirements
- To create design concepts and generate creative device features to best meet user requirements;
- To establish technical solutions for complex problems requiring ingenuity and creativity; make practical device development plan to ensure timely delivering of device deliverables
- To oversee engineering tests for design verification and HF studies for validation
- To create industrialization strategies and apply extensive expertise as a specialist in process development and process validation for high volume injection molding of plastic parts, sub-assembling and final assembling of combination products
Supports the device platform team by utilizing a forward-looking perspective to contribute to "go/no go" decisions for new platform device introduction
Applies critical thinking to solve complex issues while multi-tasking in a fast-pace working environment. Strong matrix management skills needed to fulfill multi-functional collaborations with both internal and external partners in device development and manufacture
Internally recognized as an expert by the Medi device cross functional group through internal presentations and critical contributions to device development by championing best practice technologies, device component tooling, automation, validation and change management. Education and Experience :
Bachelor's Degree in mechanical engineering, biomedical engineering, materials science or related engineering fields with 10+ years of device development/manufacturing experience in medical device or pharmaceutical industry. Post-graduate degree in the related engineering fields is an asset.
Product development experience in the area of biologics delivery and devices including auto injectors, pre-filled syringe, pen injectors and/or large volume bolus injectors is a must. Proven experience in launching of combination product through the entire development cycle in a CMC environment is highly desired
Excellent written and verbal communication skills are vital.
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.