Engineer - Risk Management, Combination Product Operations Risk Engineering (CPO-RE)

Career Category
Engineering
Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer - Risk Management, Combination Product Operations Risk Engineering (CPO-RE)

What you will do

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

Amgen is currently seeking an Engineer in our Combination Product Operations Risk Engineering (CPO-RE) team. In support of Amgen's 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 Engineer will be responsible for contributing to the development and lifecycle management of the Risk Management Files (RMFs) for Amgen's portfolio of products. The Engineer will contribute to risk assessments such as System Risk Assessments and Use Risk Assessments in close coordination with respective multi-functional teams. This includes working with the Complaints, Safety, Human Factors, and other teams to support life cycle management.

The Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing CPO-RE in corresponding audits. Responsibilities will also include supporting the advancement of design controls activities/processes, the continued advancement of risk assessment processes, methods and tools, and business processes for ongoing continuous improvement.

Responsibilities include but are not limited to:

• Ensures Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971.
• Contributes to creation and maintenance of Risk Management Files.
• Participates in risk assessments and contributes to risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.
• Contributes to hazard analyses, use risk assessments, and system risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.
• Contributes to process improvement efforts for Risk Management.
• Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures.
• Participates in 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 program outcomes, communicates effectively at multiple organizational levels, facilitates development of solutions to critical business issues, and effectively defines objectives to enable effective metrics generation and reporting.
• Understands manufacturing processes for Amgen's 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:

• High school diploma / GED and 8 years of risk management, engineering, and/or medical device experience OR
• Associate's degree and 6 years of risk management, engineering, and/or medical device experience OR
• Bachelor's degree and 2 years of risk management, engineering, and/or medical device experience

Preferred Qualifications:

• 2 years industry experience in development of medical devices or drug delivery technologies for therapeutic products through commercial entry
• Working knowledge and familiarity with the following:
  
  • US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485).
  • Drug-Device and Biologic-Device Combination Product Requirements for cGMP.
  • ISO 14971 (2019).
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Proven ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations
• Experience working with multi-functional groups, including complaints intake and complaints investigation teams.
• Capable of managing multiple projects in a deadline driven environment.
• Strong oral and written communication skills, decision making, presentation, and organization skills
• Demonstrated ability to navigate ambiguity and provide a structured problem-solving approach
• Organizational savvy and presence to build effective relationships across functions
• Track record of building or participating as a member of high performing teams
• Working knowledge of MS Office tools, including artificial intelligence
• Working knowledge of digital PLM platform tools

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

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

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.

Salary Range
93,344.00 USD - 107,268.00 USD

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