Staff Systems Engineer, Manufacturing

Enable Injections

On-site
Bachelor's degree in technical discipline
8 years manufacturing operations experience
Regulated environment experience
Enable Injections is seeking a Staff Systems Engineer for their manufacturing operations, requiring extensive experience in regulated environments and a strong focus on equipment development. The ideal candidate will possess a technical background, excellent problem-solving skills, and the ability to lead cross-functional initiatives

Job Summary

  • The role involves revamping and standardizing the equipment procurement process while coaching engineers on documentation.
  • Candidates will serve as a subject matter expert for SAP manufacturing processes and lead PFMEA framework development.
  • The position requires managing cross-functional initiatives to support site expansions and third-party CMO integrations.

Matching Summary

Match Score: 85

Enable Injections is seeking a Staff Systems Engineer for their manufacturing operations, requiring extensive experience in regulated environments and a strong focus on equipment development. The ideal candidate will possess a technical background, excellent problem-solving skills, and the ability to lead cross-functional initiatives.

Skills & Requirements

Must-have

  • Bachelor's Degree in technical discipline
  • 8 years manufacturing operations experience
  • Regulated environment experience
  • Equipment development and quality systems
  • SAP or similar enterprise manufacturing systems
  • Cross-functional initiative leadership
  • Root-cause analysis and risk management

Nice-to-have

  • Medical device manufacturing experience
  • Labeling and packaging system expertise
  • eDHR implementation familiarity
  • Equipment procurement process knowledge
  • Lean Six Sigma certification
  • Digital manufacturing systems experience

Key Requirements

  • Bachelor's Degree in Engineering or Science
  • Minimum 8 years supporting manufacturing operations
  • Experience in regulated environments
  • Knowledge of PFMEA and control plans

Work Rights

Not specified

Tailored Resume

Cover Letter