Principal Engineer Risk Management
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Live
What you will do
Lets do this! Lets change the world!
Amgen is currently seeking a Principle Engineer in our Final Products and Technology Risk Management (FPT-RM) team. In support of Amgens mission to serve patients, FPT-RM is a diverse team developing and continuously improving our drug delivery devices and combination products to ensure supply and to optimize the patient experience.
The Principle Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMF) for Amgens portfolio of products, serve as Risk Management lead on assigned projects, and support team management assignments.
The Principle Engineer will demonstrate leadership skills to actively engage with multi-functional groups to support cross functional processes collaborating with Risk Management.
The Principle Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing FPT-RM in corresponding audits. Responsibilities will also include the continued advancement of risk management processes, methods and tools, and business processes for ongoing continuous improvement.Responsibilities:
- Ensures Quality Risk Management Files are in alignment with MDR, 21CFR Part 820 design control and risk management requirements of ISO 14971 for all Amgen commercialized combination products, as well as other applicable standards/guidance.
- Successfully influences outcomes, communicates with all levels of the organization, facilitates development of solutions to critical business issues, and effectively defines objectives to enable effective metrics generation and reporting
- Creates and maintains the Risk Management Files (RMFs).
- Conducts risk assessments and creates/revises risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.
- Management of hazard analyses, design risk assessments, use risk assessments, system risk assessments, and process risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.
- Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures
- Leads periodic and event driven risk reviews of the RMFs for commercialized products
- Supports 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
- Understands manufacturing processes for Amgens packaged and/or distributed products
- Supports root cause analysis of complaint investigations
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have with these qualifications.Basic Qualifications
- Doctorate degree and 3 years of risk management or engineering experience; OR
- Masters degree and 5 years of risk management or engineering experience; OR
- Bachelors degree and 8 years of risk management or engineering experience; OR
- Bachelors or Masters Degree in Engineering, preferred Mechanical Engineering, Electrical Engineering, Systems Engineering, Materials Engineering, or Bio-Medical Engineering.
- 10 or more years of experience with risk analysis methods such as PrHA and FMEA for medical devices
- 8 or more years of experience in a Medical Device Development or Device Risk Management role
- 5 or more years of proven experience with Medical Device Reporting requirements, preferably for the European Union
- Ability to converse technically with mechanical, electronic, software, and quality engineers
- Experience with risk management per ISO 14971
- Experience in leadership role(s) and mentoring
- Experience working with multi-functional groups
- 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
- Capable of managing multiple projects in a deadline driven environment, and coordinate resources to achieving project objectives.
- Strong verbal, technical writing, and interpersonal skills
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.