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