Senior Engineer - Amgen

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Engineer

What you will do

Let's do this! Let's change the world!

Amgen is currently seeking a Sr. Engineer in our Combination Product Operations Risk Engineering (CPO-RE) team for Risk Management. In support of Amgens mission to serve patients, the CPO-RE 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, serve as Risk Management lead on assigned projects, and support Design Control processes and activities.

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 Risk Management File, as well as support multi-functional processes collaborating with Risk Management. This includes working with the Complaints, Safety, Human Factors, 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-RE in corresponding audits. The Sr. Engineer will assist with the advancement of design controls activities/processes, the continued advancement of risk assessment processes, methods and tools, and business processes for ongoing continuous improvement.

• Ensures Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971.

• Creates and maintains the Risk Management Files.

• 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.

• Creates and maintains hazard analyses, use risk assessments, and system risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.

• Contribute to process improvement efforts for Risk Management and Design Controls.

• 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 Risk Management Files 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications

• Doctorate degree OR

• Masters degree and 2 years of Engineering and/or Operations experience OR

• Bachelor's Degree and 4 years of Engineering and/or Operations experience OR

• Associate's degree and 8 years of Engineering and/or Operations experience OR

• High school diploma/GED and 10 years of Engineering and/or Operations experience

• 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.

• Extensive experience with risk management per ISO 14971 (2019).

• Experience with Design Controls, 21 CFR 820 (820.30 Design Controls).

• Experience in 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.

What you can expect of us

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.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

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

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 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.