Senior Engineer with a focus on documentation and DHF, Amgen Denmark Device Engineering @Amgen

Job Information

Job Description:

Responsibilities:

  • Provide direction and support all technical documentation (Device Design/Testing, Design Outputs, Manufacturing equipment/process/control)
  • Drive and be accountable for DHF documentation to ensure a clear line between platform, combination product and vendor DHF structuring
  • Own risk assessment integration between requirements, risks, mitigation implementation within Design Outputs
  • Provides oversight of the feedback loop from DIR through Risk Assessments to the Design Outputs and back
  • Manages / maintains the traceability between risk (Use and Functional) and Requirements
  • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones
  • Participate in project execution according to Robust Design paradigm and principles: kinematics, tolerance design, 2D drawings, structural analysis (FEA), materials science (especially polymers), DfM/DfA
  • Apply project planning and monitoring methods to ensure timely completion
  • Review and approve completed design work

Preferred Qualifications:

  • 10+ years of progressive experience as an engineer or scientist within the appropriate field of study
  • 5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III
  • Fluent in English language
  • Understands documentation flow for GMP deliverables
  • Solid experience in documentation authoring from project start to end, and under Design Controls
  • Technical understanding of drawings
  • Technical understanding of manufacturing processes (injection molding, assembly processes)
  • Experience in drug/device combination product design and development
  • Demonstrated experience with ISO and regulatory compliance process, Design History File
  • Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
  • Experience in model-based design and UML and small-scale device assembly experience
  • Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)
  • Deep 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; Risk Management – ISO 14971; EU Medical Device requirements – Council Directive 93/42/EECStrong background in documenting requirements and providing traceability documentation for FDA Approval
  • Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts
  • Strong interpersonal skills
  • Strong communication and presentation skills
  • Ability to work within cross-cultural project teams

Benefits:
Experience Level: Senior
Work From: Onsite

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