Sr Engineer

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this. Lets change the world.

Amgen is currently seeking a Sr. Engineer in our Combination Product Operations Risk Management (CPO-RM) team. In support of Amgens mission to serve patients, the CPO-RM team at Amgen is a diverse team working to develop and continuously improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience. The Sr. Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMFs) for Amgens portfolio of products, as well as serving as Risk Management lead on assigned projects. The Sr. Engineer will create/maintain risk assessments such as System Risk Assessments and Use Risk Assessments with close coordination with respective multi-functional teams. The Sr. Engineer will bring to bear leadership skills to actively engage with multi-functional groups to support the RMF, as well as support multi-functional processes collaborating with Risk Management. This includes working with the complaints, safety, and other teams to support life cycle management. The Sr. Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing CPO-RM in corresponding audits. Responsibilities will also include the continued advancement of risk assessment processes, methods and tools, and business processes for ongoing continuous improvement.

• Ensures Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971 for all Amgen commercialized combination products.

• Creates and maintains the 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

• 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 Amgens packaged and/or distributed products

• Supports root cause analysis of complaint investigations

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The risk management professional we seek is an employee with these preferred qualifications.

Basic Qualifications

• Doctorate degree; OR

• Masters degree and 3 years of risk management or engineering experience; OR

• Bachelors degree and 5 years of risk management or engineering experience; OR

• Associates 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:

• Bachelors or Masters Degree in Engineering, preferred Mechanical Engineering, Electrical Engineering, Systems Engineering, Materials Engineering, or Bio-Medical Engineering.

• 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 is leadership role(s) and 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

• Ability to converse (oral and written) technically with mechanical, electronic, software, and quality engineers

• Capable of managing multiple projects in a deadline driven environment

• Strong technical writing and interpersonal skills

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.