Are you an experienced Senior Systems Engineer (SSE) searching for a role within Inhalation Product Development and would like to use your expertise in a company that follows science and turns ideas into life-changing medicines? If so, join our team at AstraZeneca in Research Triangle Park North Carolina.
We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people’s lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalization, and sustainable practices.
AstraZeneca is at an exciting time of new products and launches. We get to work with innovative and scientific products on our leading-edge end-to-end supply chain, using the latest technologies and modern facilities.
AstraZeneca Durham has expanded and strengthened its respiratory products portfolio, delivering approvals and launches for multiple global inhalation products, with a robust pipeline in development. Our mission, through dedication to creating a culture of inclusion and teamwork, is to develop innovative therapeutics for respiratory diseases and conditions including asthma and COPD. This site is responsible for the product, device, process, and analytical development of new inhalation products in the AZ portfolio. The site also manufactures and packages clinical supplies to meet clinical trial demands. Join us in Durham, NC, which is situated in Research Triangle Park; the leading center of innovation in the Southeast!
As an SSE, you will lead and support design and development aspects of new device (Medical Device and Combination Products) development projects. The role also requires project management skills, a detailed understanding of design work and design control procedures, and close collaboration with other AZ functions, external suppliers, and consulting partners. The ideal candidate will have extensive device engineering experience in combination products including combination inhalation products and working knowledge of medical device design controls including system engineering. In addition, the candidate should have strong problem-solving and communication skills with the drive and hands-on leadership qualities needed to deliver on challenging project goals.
What will you do:
Effectively lead, guide, and mentor a team of internal and external technical resources to deliver Medical Device and Combination Products including state-of-the-art inhaler devices.
Responsible for user needs derivation and product requirements management (including full traceability), risk management, technical planning, design reviews, verification and validation, design transfer, project scheduling, and budgeting
Perform/participate in Risk Management activities, such as FMEA, and Hazard Analysis activities.
Support human factors usability studies and other applicable validation activities.
Represent IPD device development on Pharmaceutical Project Teams, ensures the provision of appropriate data (technical, resource, and budgetary)
Foster collaboration internally with Product Development, Analytical Services, Manufacturing, Quality, Regulatory, Human Factors to effectively deliver on Inhalation Product Development (IPD) goals.
Author/review design control and device development activities for inhalation drug-device combination product development to ensure compliance with 21 CFR 820.
Essentials:
Education/Required:
Ph. D. / 5 years; MS / 8 years; BS / 10 years of relevant (medical device or combination product) industry experience. Degree in Mechanical, Biomedical, System Engineering, or other Engineering fields.
Required:
Consistent record of success in device development leadership, project planning, and problem-solving for Medical Devices and/or Combination products, preferably inhalation products in a pharmaceutical environment.
In-depth knowledge of GMP as well as a medical device and combination design controls, product guidance, standards, and directives
System Engineering, Human Factors and Risk Management experience
Experience working with external vendors
Computer skills with demonstrated experience in working with Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Desired:
Subject matter expert on inhalation (MDI, DPI) drug-device combination product development
Knowledge of equipment, methods, procedures, and data interpretation required for aerosol testing applied to inhalation dose forms
Electromechanical connected device experience
Lean experience
Requirements management traceability tools experience
Why AstraZeneca
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.
So, what’s next
Are you already originating yourself joining our team? Good, because we can’t wait to hear from you!
Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
Date Posted
25-Jul-2021Closing Date
17-Aug-2021AstraZeneca 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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