Do you have expertise and passion for device development and would like to apply your expertise with a company that follows the science? If so, AstraZeneca would be an excellent fit for you.
At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
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 building 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!
We are looking for an experienced Associate Principal Device Engineer (APDE) to work within our Inhalation Device Development team. As an APDE you will lead and support the design and development aspects of new device (Medical Device and Combination Products) development projects. The position will require strong problem-solving and communication skills with the drive and hands-on leadership qualities needed to deliver challenging project goals. The successful candidate will have an understanding of design work and design control procedures, and close collaboration with other AZ functions, external suppliers, and consulting partners.
What will you do:
- 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.
- Accountable for end-to-end design control deliverables including user needs, product requirements management (including full traceability), risk management, technical planning, design reviews, verification and validation, design transfer, project scheduling, and budgeting
- Participate in Risk Management activities, such as FMEA, and Hazard Analysis activities according to MDR, ISO 14971.
- Represent IPD device development on Pharmaceutical Project Teams, ensuring the provision of appropriate data (technical, resource, and budgetary)
- Foster collaboration internally with Product Development, Analytical Services, Manufacturing, Quality, Regulatory, Risk Management, and Human Factors to effectively deliver on Inhalation Product Development (IPD) goals.
- Author/review/approve design control and device development activities for inhalation drug-device combination product development to ensure compliance with 21 CFR 820, EU MDR. Author device regulatory sections in filings and support internal and external audits.
- 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.
- Successful in device development leadership, project planning, and problem-solving for Medical Device and/or Combination products, preferably inhalation products in a pharmaceutical environment.
- Working knowledge of medical device design controls including system engineering.
- Project management skills
- In-depth knowledge of GMP, product guidance, standards, and directives
- Experience working with external vendors
- Computer skills with demonstrated experience in working with Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Subject matter expert on inhalation (MDI, DPI) drug-device combination product development
- Extensive device engineering experience in combination products including combination inhalation products
- System Engineering, Human Factors, and Risk Management experience
- Knowledge of equipment, methods, procedures, and data interpretation required for aerosol testing applied to inhalation dose forms
- Experience working with electromechanical connected devices and requirements management traceability tools
- Lean experience
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 entrepreneurial - 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, groundbreaking cutting-edge methods, and bringing unexpected teams together. Interested - Come and join our journey.So What's Next
Are you already imagining yourself joining our team - great because we can't wait to hear from you!Find out more on Social Media:
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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