Senior Engineer

Career Category

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

What you will do

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

In support of Amgen’s mission to serve patients, the Development Product Engineering Organization at Amgen is a diverse team responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgen’s portfolio of therapeutic products.

The Senior Development Engineer works as part of a multi-disciplinary program team to create drug delivery solutions which meet user requirements for Amgen’s portfolio of therapeutic products from concept through commercial entry. The Senior Development Engineer advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for concept and development stage solutions to serve user needs and the needs of the pipeline portfolio, leveraging a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.

Responsibilities include but are not limited to:

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
• Accountability of maintaining technical records within design history file associated with assigned products
• Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
• Communicate effectively at multiple organizational levels on project status, risks, issues, and accomplishments.
• Provide guidance on combination product and device design requirements and specifications
• Analyze data to support design acceptance, performance capability, and failure analysis
• Create and drive 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
• Engage suppliers and development partners regarding specifications and quality levels
• Provide authorship and expert technical leadership for regulatory filings
• As part of the team working on device platforms, ensure adherence to architecture to support variations of the platform and system deliverable packages.
• Owns and support quality records, change records, and deviations
• Collaborate with Process Development and external partners as a technical authority.

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 experience OR
• Associate’s degree and 8 years of Engineering experience OR
• Bachelor’s degree and 4 years of Engineering experience OR
• Master’s degree and 2 years of Engineering experience OR
• Doctorate degree

Preferred Qualifications:

• 6+ years industry experience in development of 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.
  • Physical test method development, qualification, and validation.
  • ISO 14971 and ISO 11608.
  • Laboratory equipment and techniques for device development and testing.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Strong problem-solving skills
• Capability to advance multiple projects in a deadline-driven environment
• Strong oral and written communication skills, decision making, presentation, and organization skills
• 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
• 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

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 annual base salary range for this opportunity in the U.S. (excluding Puerto Rico) is [salary range].

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

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.

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