Principal Systems Engineer

6 days ago


Cambridge, Massachusetts, United States Amgen Full time
Job Title: Principal Systems Engineer

Amgen is seeking a highly skilled Principal Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the success of multi-functional drug delivery and combination product development efforts.

Key Responsibilities:
  • Lead the development of robust combination products / drug device combinations for global markets using best Systems Engineering principles.
  • Lead formal and ad-hoc technical and design reviews for the integrated system.
  • Spearhead system definition in conformance to global regulatory guidance and best engineering methods.
  • Ensure quality through integration of requirements, risks, and implemented mitigations through downstream design outputs.
  • Drive system verification and validation strategies across platform and brand-specific presentations.
  • Own system performance & reliability targets and subsystem allocations.
  • Provides authorship and expert technical leadership for regulatory filings.
  • Responsible for mentoring, supervision, and directed professional development of more junior engineers.
Requirements:
  • Doctorate degree and 2 years of Engineering experience, or Master's degree and 4 years of Engineering experience, or Bachelor's degree and 6 years of Engineering experience, or Associate's degree and 10 years of Engineering experience, or High school diploma / GED and 12 years of Engineering experience.
  • Prior personnel management experience.
  • Master's Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering.
  • 10+ years of demonstrated success in medical device, drug delivery, or combination product / drug-device combination development for clinical entry and market lifecycle.
  • 5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products / drug device combinations through product lifecycle.
What We Offer:
  • 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.
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
  • Stock-based long-term incentives.
  • Award-winning time-off plans and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements, where possible.


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