If you have experience with Risk Management, this job will be a great fit for you! If you enjoy working with a variety of innovative products that make a difference in people's lives and working with a variety of programs with cross-functional teams, this is the job you have been waiting for! As a Risk Management Engineer, you will be located at our Durham, NC Research Triangle Park site, the leading center of innovation in the Southeast!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, 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.

Make a meaningful contribution to device development for combination products in the Inhaler Product Development (IDP) team by creating and maintaining the Risk Management File (RMF) for our products in compliance with global regulatory requirements. Be involved in a wide range of device projects in different stages of our product development process, interact closely with device engineering, human factors, regulatory, clinical, quality and external partners.

**This position will be filled at either an entry level (Grade C) or more experienced level (Grade D) depending on experience and qualifications**

Responsibilities include but are not limited to:

• Lead product risk management activities according to ISO14971 and 21 CFR Part 820 (including creation of Risk Management Plan, FMECAs, Fault Tree Analysis and Risk Management Report)
• Work closely with Quality on risk management SOPs, procedures and process improvements
• Maintain RMF for products in compliance with regulatory requirements.
• Identification of risk inputs from similar commercial products, literature, agency complaints database
• Work with design engineers to assess product design risks, drive mitigations and evaluate effectiveness of control measures
• Work with human factors engineers to assess use related risks, drive mitigations and evaluate effectiveness of control measures

Qualifications:

Required:

Grade C:

• Bachelor’s degree in Engineering with a minimum of three (3) years risk management engineering experience OR

Grade D

• Bachelor’s degree in Engineering with a minimum of five (5) years risk management engineering experience OR
• Master’s or doctorate degree in engineering and a minimum of three (3) years of risk management or engineering experience​

Preferred:

• Degree in engineering preferably Mechanical, Electrical or Biomedical Engineering
• Minimum of three (3) years in Fault tree analysis, and/or other risk analysis methods such as FMEA for medical devices or combination products
• Minimum of three (3) in Medical Device Development or Risk Management Role for medical devices or combination products
• Experience with risk management per ISO 14971
• Experience with inhaler devices
• Ability to converse technically to engineers and cross-functionally

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 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.

Next Steps – Apply today!

Are you ready to bring new ideas and fresh thinking to the table? We have one seat available, and we hope it’s yours. Curious to know more, then 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. Know someone who would be a phenomenal fit, please share this posting with them.

Find out more on Social Media:

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• About Operations: https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

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.