Senior Engineer - Combination Product & Medical Device Risk Manager

Thousand Oaks, CA, US
Aug 09, 2019
Required Education
High School or equivalent
Position Type
Full time
Senior Engineer - Combination Product & Medical Device Risk Manager

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Amgen is currently seeking a Senior Engineer in our Design and Development group. In support of Amgen's mission to serve patients, the Design and Development group at Amgen is a diverse team working to continuously develop and improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience. The Senior Engineer will be responsible for the following:

Job Responsibilities:
  • Maintain the Risk Management Files (RMF) for Amgen products, including all development and post-market requirements.
  • Support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities
  • Interface with the development teams and change management teams to assess risk (design/user/system/process) for manual, mechanical and electromechanical devices and create or update the RMF
  • Interface with the complaints and safety teams to support life cycle management
  • Provide feedback to product development teams regarding observed design-related and user-related failure modes
  • Maintain close interaction with the engineering, human factors and quality functions to contribute to product development and improvement.
  • Ensure 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.
  • Create and maintain the Risk Management Files
  • Conduct risk assessments and create/revise 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.
  • Work with design engineers to assess design changes from systems perspective, identifying risks, driving design mitigations and evaluating effectiveness of the risk control measures
  • Lead 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
  • Support the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements
  • Successfully influence outcomes, communicate 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
  • Understand manufacturing processes for Amgen's packaged and/or distributed products
  • Support root cause analysis of complaint investigations

Basic Qualifications
  • 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

Preferred Qualifications
  • Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed
  • 6 or more years of experience with risk analysis methods such as PrHA and 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
  • 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 Next Generation requirements management software
  • Strong technical writing and interpersonal skills

Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients. And every step of the way, we are guided by the values that define us.

Amgen 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.

Join Us

If 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.