Posted 1w ago

Staff Systems Engineer, Manufacturing (Cincinnati, OH, US, 45241)

@ Enable Injections
Cincinnati, Ohio, United States
OnsiteFull Time
Responsibilities:Revamp and standardize process, Create templates and guidance documents, Coach engineers on equipment documentation
Requirements Summary:Bachelor’s in technical discipline; 8+ years in regulated manufacturing; experience with equipment development, quality systems, and manufacturing process controls; SAP; cross-functional leadership; PFMEA/risk mgmt.
Technical Tools Mentioned:SAP, Bartender, eDHR
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Job Description







Location: Onsite


Status Type: Full Time


 


QUALIFICATIONS


 


Required:



  • Bachelor’s Degree in technical discipline (e.g., Engineering or Science)

  • Minimum of 8 years of experience supporting manufacturing operations in a regulated environment

  • Demonstrated experience with equipment development, quality systems, and manufacturing process controls

  • Familiarity with SAP or similar enterprise manufacturing systems

  • Experience leading cross-functional initiatives or projects

  • Strong problem‑solving, root-cause analysis, and risk‑management skills

  • Knowledge of risk management tools such as PFMEA, control plans, and structured root cause analysis


 


Preferred:



  •  Experience with medical device manufacturing or other highly regulated industries

  • Experience with labeling/packaging systems (e.g., Bartender), packaging operations, and printer integration

  • Familiarity with eDHR implementation or digital manufacturing systems

  • Experience with equipment procurement process (URS, FAT/SAT, characterization)

  • Knowledge of PFMEA, control strategy development, or structured risk assessment

  • Lean, Six Sigma, or similar continuous improvement training or certification


 


Skills & Competencies:



  • Systems thinker who connects equipment, process, software, documentation, and quality requirements into coherent frameworks

  • Organized and proactive; drives accountability across teams

  • Strong communication and technical writing skills

  • Ability to influence and build alignment cross-functionally

  • Comfortable with ambiguity and able to create structure where none exists

  • Able to manage and prioritize multiple initiatives

  • Ability to develop and manage project timelines to drive completion


 


Physical Requirements:



  • Ability to remain in a stationary position for extended periods

  • Ability to operate a computer and standard office equipment


 


RESPONSIBILITIES:



  • Revamp and standardize process for equipment procurement and implementation

  • Create templates and guidance documents for equipment development

  • Coach engineers on equipment documentation

  • Refine Corrective Maintenance (CM) versus Change Control (CC) pathways

  • Evaluate and recommend enhancements to engineering change categorization

  • Serve as ME approver for CCs and provide coaching to engineers authoring change controls

  • Serve as internal expert for SAP manufacturing processes

  • Restart and maintain SAP equipment documentation effort

  • Support future digital initiatives including eDHR and facility expansions

  • Own and maintain OPs, routers, and packaging and labeling processes

  • Partner with PD labeling SMEs and IT to ensure compliant execution

  • Provide ME input into site expansion strategy and third-party CMO integration

  • Serve as project manager for ME deliverables associated with packaging initiatives

  • Lead PFMEA framework development and updates

  • Establish equipment requirement specifications

  • Act as ME approver for DMRs and other documentation

  • Champion simplification and standardization

  • Lead cross-functional improvement initiatives

  • Support higher‑level systems such as SPC, line control, and traceability

  • Develop project schedules and define deliverables