Senior Device Engineer

Gaithersburg, MD

Employer:	AstraZeneca
Job Type:	Full Time
Description
Senior Device Engineer Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. Summary of the group: The Device Development Group sits in the BioPharmaceutical R&D organization. The group is responsible for design, development, healthcare authority approval and ultimately the launch of drug/device combination products. The product portfolio is mainly focused on subcutaneous drug delivery systems and has several new Technology Development projects. Main Duties & Responsibilities: Lead or be a strong technical contributor to a multi-functional team in the selection, development, scale up and/or commercialization of primary containers and/or drug delivery devices for the AstraZeneca pipeline Leads or participates in technically demanding projects within specific area or field of expertise. Applies engineering principles for the design and development of robust devices/methods/processes that meet patient, molecule and business needs. Strong technical capability in solving complex problems using tools such as: mechanistic and statistical modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma Contribute to departmental combination product and primary container development capability by applying and maintaining a high level of knowledge and expertise Influence and educate multi-functional stakeholders and leaders on device development, primary container and commercialization standard processes Strong knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual's discipline (e.g. risk management, Design Controls, FDA QSR, ISO13485, ISO standards etc.) Establish a close working relationship with and provide effective oversight of suppliers and lead technical aspects of external collaborations Drive a Quality mentality and ensure that work is performed in accordance with appropriate quality requirements and compliance to standards Contribute to regulatory filings and health authority responses as well as develop and implement standard methodologies and business processes Education & Experience Requirements: Bachelor's and 8+ years of experience or Master's degree and 6+ years of experience in engineering or related field. Required Skills: Excellent leadership skills as well as excellent engineering and technical skills Experience and thorough understanding of parenteral medical device and/or combination product development Demonstrated experience of product characterization, design controls and risk management Experience working on multi-functional development teams and a track record of working effectively within a matrix organization and collaborative environment Excellent communication skills (both written and oral) to summarize development work, critical conclusions and its relevance to the bigger picture Demonstrated experience in one or several of the following areas: new technology development, product development, human factors, test methods development, device/process characterization, design controls, risk management Familiarity with industry standards and practices applicable to primary container, device and/or combination product development is required. Desired Skills: Experience in development of drug/device combination products for subcutaneous delivery Experience leading multi-functional development teams Experience working with external development and commercialization partners and suppliers When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey . So, what's next? Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours. Where can I find out more? Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=e n The annual base pay (or hourly rate of compensation) for this position ranges from $ 104,270.40 to $ 156,405.60 , either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Senior Device Engineer

Gaithersburg, MD

Description