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 belocated 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.
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
Bachelor's degree and a minimum of five (5) years risk management engineering experience OR
Master's or doctorate degree and a minimum of three (3) years of risk management or engineering experience
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
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.