Staff Systems Engineer, Manufacturing

Enable Injections Inc.•Sharonville, OH

1d•Onsite

About The Position

This is a full-time, onsite Staff Systems Engineer position focused on manufacturing operations. The role requires a minimum of 8 years of experience in a regulated manufacturing environment, with a strong emphasis on equipment development, quality systems, and process controls. The successful candidate will be responsible for leading cross-functional initiatives, standardizing processes, coaching engineers, and supporting digital manufacturing systems. Key areas include equipment procurement, SAP manufacturing processes, packaging and labeling, and continuous improvement efforts.

Requirements

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
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

Nice To Haves

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

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