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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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Job Responsibility:
Lead end-to-end preparation and execution of Change Controls, including defining scope, rationale, and supporting documentation
Partner with Change Owners, Document Owners, and SMEs to align timelines, impact assessments, and approvals
Author and/or support redlining and finalization of controlled documents
Ensure completeness, accuracy, and compliance of change records within the Quality Management System
Support presentation of changes at Change Control Boards (CCBs)
Support development and maintenance of the Design History File
Support tasks within one or more of the Design for Robustness disciplines: Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM
Collaborate across robustness disciplines to identify risks and mitigations, opportunities, and best trade-off solutions
Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures
Apply systems-level thinking to anticipate how design decisions impact downstream manufacturability and performance
Requirements:
Master's degree
OR Bachelor's degree and 2 years of Engineer experience
OR Associate's degree and 6 years of Engineer experience
OR High school diploma / GED and 8 years of Engineer experience
Nice to have:
2+ years of progressive experience as an engineer or scientist within a research & development, manufacturing, or engineering environment
Experience with change control and configuration management in regulated environments
Experience authoring technical documentation and working within a QMS
Experience in medical device or combination product development under Design Controls
Understanding of manufacturing processes (e.g., injection molding, assembly processes)
Familiarity with technical drawings and specifications
Working knowledge of relevant standards (21 CFR 820, ISO 13485, ISO 14971)
Strong communication and cross-functional collaboration skills
Ability to work with teams across functional areas, cultures, and time zones
Fluent in English language
What we offer:
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