Sr Device Assembly Engineer

Senior Device Assembly Engineer

Responsible for providing technical leadership for the commercial Confi Pen device assembly platforms throughout the product lifecycle, including design, testing, manufacturing support, continuous improvement, and global commercialization of drug-device combination products.

• Product Development & Lifecycle Management
  :
  Lead design change implementation, lifecycle management, and compliance with design control requirements for Confi Pen devices and drug-device combination products.
• Technical Leadership
  :
  Lead cross‑functional engineering teams, provide subject‑matter expertise, mentor junior engineers, and manage project scope, schedules, budgets, and technical risks.
• Engineering Laboratory & Process Development
  :
  Conduct investigations, process development, DOE, and laboratory testing to support product development, lifecycle management, and continuous improvement.
• Verification, Validation & Testing
  :
  Develop verification strategies, author protocols, reports, and technical documentation; analyze data to support design acceptance and product performance.
• Manufacturing Support
  :
  Support technology transfer, scaling, troubleshoot automated assembly/testing equipment, and utilize manufacturing data for continuous improvement.
• Assembly Process Monitoring & Process Optimization
  :
  Investigate automated assembly equipment, analyze force‑displacement signatures, optimize assembly parameters, and validate process windows.
• Quality & Regulatory Compliance
  :
  Own engineering change records, lead root‑cause investigations, support DFMEA/PFMEA and regulatory submissions.
• Supplier & External Partner Management
  :
  Collaborate with suppliers on specifications, qualification, and component investigations.

• Knowledge of 21
  
  CFR
  820.30 and global medical device design control processes.
• Experience with DOE, statistical analysis, and process capability.
• Hands‑on expertise in force‑displacement monitoring, assembly equipment troubleshooting, and manufacturing data analysis.
• Proficiency with Solid Works, CAD, Minitab, JMP, or equivalent statistical software.
• Strong project management, communication, technical writing, and cross‑functional leadership skills.

• Doctorate, Master’s degree and 2years Engineering/Operations experience; or Bachelor’s degree and 4years Engineering/Operations experience; or Associate’s degree and 8years Engineering/Operations experience; or High school diploma/GED and 8years Engineering/Operations experience.

• Bachelor’s degree in mechanical, biomedical, manufacturing engineering, or related discipline.
• 7+years engineering experience supporting medical devices or combination products.
• 5+years supporting manufacturing or commercial operations.
• Experience with drug delivery systems, automated assembly equipment, and in‑process monitoring technologies.
• Knowledge of 21
  
  CFR Part
  820, ISO
  13485, ISO
  14971, EU MDR, and combination product regulations.

Expected annual salary range: $ – $ USD (excluding Puerto Rico).

Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations will be provided to individuals with disabilities.