Device Engineering Sr Engineer Cambridge MA
Cambridge, MA - USA
Job Summary
What you will do
Lets do this. Lets change the this vital role you will join our Device Engineering group to support device development and engineering support of Amgens 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.
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.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree
OR
Masters degree and 2 years of Engineering experience
OR
Bachelors degree and 4 years of Engineering experience
OR
Associates degree and 8 years Engineering experience
OR
High school diploma / GED and 10 years of Engineering experience
Preferred Qualifications:
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
Salary Range
115494.60USD -156257.40 USD
Required Experience:
Senior IC
About Company
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