Title:  Staff Systems Engineer, Manufacturing

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