Device Engineering Sr. Engineer

Amgen • Cambridge, MA

3d • 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. Device Engineering Sr. 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 device development and engineering robustness. 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 Sr Engineer role is a cross-discipline execution role within the Design for Robustness framework. The role ensures consistent and structured application of robustness methodologies across mechanical design projects, integrating insights from device performance, sources of variation, load cases, materials, assembly, and manufacturing perspectives. While not serving as the formal discipline authority, the role strengthens project robustness execution and supports discipline SMEs under centralized governance. The Sr Engineer operates across disciplines and may execute within individual Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, depending on project needs and targeted training. 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 device development team consisting of 50+ engineers. This position will report to the Robustness Disciplines Lead.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Associate’s degree and 8 years Engineering experience OR High school diploma / GED and 10 years of Engineering experience

Nice To Haves

• 5+ years of progressive experience as a mechanical engineer.
• 3+ years of experience within development of Medical Devices, ideally Class II and Class III.
• Experience in mechanical engineering disciplines and tools, with hands-on work in at least one Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, and preferably exposure to several.
• Strong interpersonal skills
• Ability to work within cross-cultural project teams
• Systematic problem solver and solution developer also when presented with conflicting needs and technical issues.
• Experience in drug/device combination product design and development
• Technical understanding of manufacturing processes (injection molding, assembly processes)
• Technical understanding of drawings and design documentation.
• Understands documentation flow for GMP deliverables
• Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
• Familiar with: US Good Manufacturing Practices - 21CFR820; Quality Management - ISO 13485; Needle-based injection systems for medical use - ISO 11608; Risk Management - ISO 14971.
• Strong communication and presentation skills
• Fluent in English language

Responsibilities

• Independently execute tasks within one or more of the Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM.
• Provide technical recommendations to improve design performance, reduce sensitivity to variation, and enhance overall system robustness
• Collaborate across robustness disciplines to identify risks and mitigations, opportunities and best trade-off solutions.
• Contribute to continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation under governance frameworks.
• Interface effectively with discipline SMEs and incorporating guidance while maintaining ownership of robustness execution within assigned scope
• Drive structured problem-solving and root cause analysis for design, test, and field performance issues, ensuring robust corrective 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: Senior
• Education Level: Ph.D. or professional degree