What are the responsibilities and job description for the Senior Engineer, Design Transfer Specialist position at Amgen?
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Engineer, Design Transfer Specialist
What you will do
Lets do this. Lets change the world. In this vital role you will participate in a technical team towards the successful design, development, and transfer of drug delivery devices. The successful candidate will be responsible for ensuring the seamless transfer of product designs from our development site to various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities :
- Design Transfer Execution : Develop and execute comprehensive design transfer plans to ensure smooth transition from design to manufacturing. Designs range from single components through full assemblies. Most of the designs will be in polymers.
- Engineering Testing : Responsible for engineering test protocol, execution & report writing, process & test development, prototyping, DOE / SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Documentation : Create and maintain detailed documentation, including design transfer plans, risk management files, and design history files.
- Collaboration : Work closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure alignment and successful design transfer.
- Vendor Management : manage vendor relationships and ensure compliance with design specifications and regulatory requirements.
- Process Validation : Oversee process validation activities, including equipment and tooling qualification, to ensure manufacturing processes meet design requirements.
- Continuous Improvement : Identify opportunities for process improvements and implement best practices to enhance design transfer efficiency and effectiveness.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.
Basic Qualifications :
Preferred Qualifications :
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, well 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 :
Apply now
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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.
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.
