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.
Engineer- Technical Investigations (Combination Device)Live
What you will do
Lets do this. Lets change the world. In this role you will report to Associate Director in Complaints Trending and Investigation group. In support of Amgens mission to serve patients, the Complaints Trending and Investigation group at Amgen is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.
The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. Responsible for authoring the assessment report and communicating the findings and results to management and multi-functional team as required. Responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis.
They will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. They will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
- Perform device assessments of complaints and document results in a report.
- Perform root cause analysis investigations for mechanical and/or electromechanical products
- Complete evaluation and deliver assessment report on time per Amgen requirements.
- Support the implementation and management of the lab infrastructure, including all equipment used for investigations
- Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
- Support characterization testing and data gathering for investigations
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineer professional we seek will possess with these qualifications.Basic Qualifications:
Bachelors degree and 2 years of related medical/biopharma development or Operations experience;
Associate degree and 6 years of related medical/biopharma development or Operations experience.Preferred Qualifications:
- Masters or Bachelors in Engineering, Science or Biomedical
- 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
- Experience in lab environment
- Demonstrated competency in root cause analysis methodology
- Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
- Strong technical writing and interpersonal skills
- Results-driven and detail-oriented
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.careers.amgen.com
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.