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

Amgen SA; Thousand Oaks (CA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Join a pioneering biotech firm dedicated to serving patients with serious illnesses. As a Senior Engineer in Risk Engineering, you will lead the development of Risk Management Files, ensuring compliance with regulatory standards while collaborating with diverse teams. This role offers the opportunity to make a significant impact on patient care through innovative drug delivery devices. With a culture that values collaboration and innovation, you will thrive in a dynamic environment focused on continuous improvement and excellence in medical device development.

Benefits

Comprehensive Employee Benefits Package

Retirement and Savings Plan

Flexible Work Models

Discretionary Annual Bonus

Stock-based Long-term Incentives

Award-winning Time-off Plans

Qualifications

• 10+ years of experience in Engineering or Operations.
• Experience with risk analysis methods for medical devices.
• Strong technical writing and communication skills.

Responsibilities

• Develop and manage Risk Management Files for products.
• Conduct risk assessments and maintain compliance with regulations.
• Collaborate with multi-functional teams to drive risk management.

Skills

Risk Analysis

FMEA

Design Controls

Technical Writing

Interpersonal Skills

Project Management

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Doctorate Degree

Tools

MS Office

Digital PLM Platform Tools

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.

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

What you will do

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

Amgen is currently seeking a Senior Engineer in our Combination Product Operations Risk Engineering (CPO-RE) team for Risk Management. 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 Sr Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMFs) for Amgen’s 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.

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.

• 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 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 10 years of Engineering and/or Operations experience OR

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

• Bachelor’s degree and 4 years of Engineering and/or Operations experience OR

• Master’s degree and 2 years of Engineering and/or Operations experience OR

• Doctorate degree

Preferred Qualifications:

• Bachelor’s or Master’s 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.

• Working knowledge of MS Office tools, including artificial intelligence

• Working knowledge of digital PLM platform tools

What you can expect from 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 and make a lasting impact with the Amgen team.

careers.amgen.com

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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. 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.