Device Engineering Sr. Engineer
Amgen
19 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Device Engineering Sr. Engineer
Responsibilities:
- Independently execute tasks within one or more Design for Robustness disciplines: Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM.
- Recommend design changes to improve performance, reduce sensitivity to variation, and enhance system robustness.
- Collaborate across robustness disciplines to identify risks/mitigations and develop trade-off solutions.
- Drive continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation.
- Partner with discipline SMEs, incorporating guidance while owning robustness execution within scope.
- Lead structured problem-solving and root-cause analysis for design, test, and field performance issues; ensure robust corrective actions.
- Collaborate with manufacturing, quality, and suppliers to improve robustness and reduce variation-driven failures.
- Apply systems-level thinking to anticipate downstream manufacturability and performance impacts.
Basic Qualifications:
- Doctorate
OR Master’s + 2 years engineering
OR Bachelor’s + 4 years engineering
OR Associate’s + 8 years engineering
OR High school/GED + 10 years engineering
Preferred Qualifications:
- 5+ years progressive mechanical engineering
- 3+ years medical device development (Class II/III preferred)
- Experience with robustness disciplines/tools; hands-on in at least one (and preferably several)
- Interpersonal skills; cross-cultural teamwork
- Systematic problem solver; drug/device combination experience
- Manufacturing process knowledge (e.g., injection molding/assembly); drawings/design documentation
- GMP documentation flow; QMS/legal knowledge; familiarity with 21CFR820, ISO 13485, ISO 11608, ISO 14971
- Strong communication/presentation; fluent English
Benefits (if eligible): Retirement/Savings, medical/dental/vision, life/disability, flexible spending, bonus/incentives, stock-based long-term incentives, time-off, flexible work models where possible.
Application Instructions:
- Apply now via careers.amgen.com.
Responsibilities:
- Independently execute tasks within one or more Design for Robustness disciplines: Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM.
- Recommend design changes to improve performance, reduce sensitivity to variation, and enhance system robustness.
- Collaborate across robustness disciplines to identify risks/mitigations and develop trade-off solutions.
- Drive continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation.
- Partner with discipline SMEs, incorporating guidance while owning robustness execution within scope.
- Lead structured problem-solving and root-cause analysis for design, test, and field performance issues; ensure robust corrective actions.
- Collaborate with manufacturing, quality, and suppliers to improve robustness and reduce variation-driven failures.
- Apply systems-level thinking to anticipate downstream manufacturability and performance impacts.
Basic Qualifications:
- Doctorate
OR Master’s + 2 years engineering
OR Bachelor’s + 4 years engineering
OR Associate’s + 8 years engineering
OR High school/GED + 10 years engineering
Preferred Qualifications:
- 5+ years progressive mechanical engineering
- 3+ years medical device development (Class II/III preferred)
- Experience with robustness disciplines/tools; hands-on in at least one (and preferably several)
- Interpersonal skills; cross-cultural teamwork
- Systematic problem solver; drug/device combination experience
- Manufacturing process knowledge (e.g., injection molding/assembly); drawings/design documentation
- GMP documentation flow; QMS/legal knowledge; familiarity with 21CFR820, ISO 13485, ISO 11608, ISO 14971
- Strong communication/presentation; fluent English
Benefits (if eligible): Retirement/Savings, medical/dental/vision, life/disability, flexible spending, bonus/incentives, stock-based long-term incentives, time-off, flexible work models where possible.
Application Instructions:
- Apply now via careers.amgen.com.