Amgen FPT Principle Product Engineer in Cambridge, Massachusetts
The Principal Engineer is an experienced professional product design engineer with a broad set of knowledge and expertise in leading sophisticated, multi-disciplinary and multi-functional product development and life cycle management efforts. It is a highly technical role requiring the ability to develop new or improvement of sophisticated electro-mechanical delivery platforms, lead investigations that involve parts of products and processes, resolve root cause and effecting engineering controls as well as corrective actions. S/he will lead technical teams towards the successful design improvements, development, and life cycle management of the drug delivery devices. The Engineer is also responsible for owning the integration of the system components as well as working with development and manufacturing partners. Assessing, supervising and mitigating technical risk and design changes is a key element to the success in this role. The Engineer will collaborate with key partners and vendors to facilitate the proper product and process design analyses and ensure customer satisfaction.
Provide Technical subject matter expertise in the given technology
Evaluate patient centric design solutions, system design concepts, and perform trade-off analyses
Develop and document strong rational for test strategy, acceptance criteria, and results
Develop and document robust tracing from design inputs through design outputs, verification, and validation
Generate, review, and/or approve protocols, reports, and other DHF documentation ensuring robust documentation for regulatory agency submission
Work with manufacturing and development teams through execution
Lead sophisticated system root cause analysis and design improvement prioritizations
Ensure compliance/closure of Regulatory and Quality requirements
Lead Formal Design Reviews and product technical review.
Conduct and review sophisticated computer simulations to craft or test products.
Basic Qualifications: Doctorate degree and 2 years of product design engineering experience
Master’s degree and 6 years of product design engineering experience
Bachelor’s degree and 8 years of product design engineering experience
Associate’s degree and 10 years of product design engineering experience
High school diploma / GED and 12 years of product design engineering experience
15+ years of dynamic experience as an engineer or scientist within the appropriate field of study.
5+ years of experience in medical device manufacturing and leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III.
Strong background root cause investigation and statistical expertise (Blackbelt preferred) Proven applied LEAN 6 Sigma proficiency.
Proven broad exposure to HW/SW/Systems design and technical depth in one or more engineering subject areas (Electrical, Mechanical, Software, etc.)
Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601)
Strong interpersonal skills and highly effective communicator
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.