Engineer

Amgen • Cambridge, MA

5d • Hybrid

About The Position

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. 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. Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will join our Device Engineering group to support change control, engineering robustness, and device development. In support of Amgen’s mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience. The role will be responsible for driving and coordinating complex, cross-functional product development efforts, with clear ownership for managing interactions, dependencies, and interfaces to ensure program execution. The successful candidate will be a key member of the technical team that progresses towards the design, development, and transfer of drug delivery devices. The role ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program. The position is based at our Amgen Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining Amgen’s device development team consisting of 50+ engineers.

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
• Experience with change control and configuration management in regulated environments
• Experience authoring technical documentation and working within a QMS
• 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

Nice To Haves

• 2+ years of progressive experience as an engineer or scientist within a research & development, manufacturing, or engineering environment
• Experience in medical device or combination product development under Design Controls

Responsibilities

• 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

Benefits

• 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 where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees