Sr. Engineer - Pfs Platform And Lyo Kit

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.

Sr. Engineer - PFS Platform and Lyo Kit

What you will do

Lets do this. Lets change the world. In this vital role you will be part of a development and sustaining device engineering team that supports final product development and ensures the product meets all requirements for safety, efficacy, and functionality. They manage the creation and maintenance of design documentation in accordance with quality procedures. They will be part of multi-functional teams responsible for the development of drug-device combination products.

• Providing guidance on combination product and device design requirements and specifications
• Leading product testing to demonstrate product safety, performance, and efficacy
• Analyzing data to support design acceptance, performance capability, and failure analysis
• Creating and driving test protocols and methods
• Transferring of technical information to manufacturing sites and support manufacturing scale-up and launches
• Employ basic engineering skills and practices to gather user requirements and translate them into documentation
• Engaging suppliers and development partners regarding specifications and quality levels
• Provides authorship and expert technical leadership for regulatory filings
• Managing project scope, schedule, and budget
• Owns and support quality records, change records, and deviations
• Collaborate with Process Development and external partners as a technical authority.

This position is located in Thousand Oaks, CA or Cambridge, MA and requires up to 10% domestic and international travel.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek possesses these qualifications.

Doctorate degree

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

Bachelors degree and 4 years of Engineering and/or Operations experience

Associates degree and 8 years of Engineering and/or Operations experience

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

• Bachelor's degree in engineering or other science-related field with 7+ years of relevant work experience with demonstrated ability in operations/manufacturing environment
• Experience in medical device, pharmaceutical or a similar regulated industry
• Background in development and commercialization of medical devices, and knowledge of manufacturing processes
• Understanding of the following standards and regulations:
• Quality System Regulation 21CFR820
• Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices ISO 14971
• EU Medical Device Regulation 2017/745
• Excellent communication and technical writing 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.

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.

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.