Sr Engineer - Risk Manager
Amgen is currently seeking a Sr. Engineer in our Commercial Advancement (CA) group. This position will report to our Director of Engineering within the CA group. In support of Amgen's mission to serve patients, the Commercial Advancement group at Amgen is a diverse team working to continuously improve our commercial drug delivery devices and combination products in order to ensure supply and to optimize the patient experience.
The Sr. Engineer - Medical Device Risk Manager will be responsible for maintaining the Risk Management Files (RMF) for Amgen products that have been commercialized, including all post-market surveillance requirements. The Sr. Engineer will interface with the change management teams to assess risk (user/design/process) associated with proposed design and manufacturing changes for both mechanical and electromechanical devices and assure the RMF is updated to reflect those changes. (S)he will also interface with the complaints and safety teams to support development of complaint codes as well as assessment of risk related to reported complaints and adverse events. The Sr. Engineer will drive periodic reviews of the RMF and support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities. (S)he will also provide feedback to product development teams regarding observed design-related and user-related failure modes. Sr. Engineer maintains close interaction with the engineering, human factors and quality functions to contribute to product improvement. Responsibilities will also include the continued advancement of risk assessment methodologies and tools.
- Doctorate degree; OR
- Master's degree and 3 years of risk management or engineering experience; OR
- Bachelor's degree and 5 years of risk management or engineering experience; OR
- Associate's degree and 10 years of risk management or engineering experience; OR
- High School diploma/GED and 12 years of risk management or engineering experience
- Ensures Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971:2012 for all Amgen commercialized combination products
- Maintains the RMF's for commercialized product as part of the Post-Market surveillance process
- Conducts risk assessments and revises risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations in support of change control and complaints intake
- Manages hazard analyses, use risk assessments, system risk assessments (e.g. device component, system level) and process risk assessments for combination products with manual, mechanical or electromechanical device, primary container and packaging constituent parts.
- Works with design engineers to assess design changes from systems perspective, identifying risks, driving design mitigations and evaluating effectiveness of the risk control measures
- Leads periodic and event driven risk reviews of the RMF's for commercialized products
- Support the complaints intake teams with assessment of risks related to reported complaints
- Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements
- Successfully influences outcomes, communicates with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting
- Understands manufacturing processes for Amgen's packaged and/or distributed products
- Support root cause analysis of complaint investigations
- Bachelor's or Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed
- 6 or more years of experience with Fault Tree Analysis, and/or other risk analysis methods such as FMEA for medical devices
- 5 or more years of experience in a Medical Device Development or Device Risk Management role
- 3 or more years of experience with Medical Device Reporting requirements, preferably for the European Union
- Experience with risk management per ISO 14971 (System Risk Analysis, Use Risk Analysis, dFMEA/pFMEA and other Risk Management tools)
- Experience working with complaints intake and complaints investigation teams
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Ability to converse technically with mechanical, electronic, software, and quality engineers
- Capable of managing multiple projects in a deadline driven environment
- Working knowledge of DOORs requirements management software
- Strong technical writing and interpersonal skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.