{"id":3762213,"url":"https://alion.io/job/enable-injections-staff-engineer-manufacturing","title":"Staff Engineer, Manufacturing","company":{"id":2363129,"name":"Enable Injections","domain":"enableinjections.com","url":"https://alion.io/company/enableinjections","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cincinnati, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design of Experiments","optional":false},{"name":"Digital Twin","optional":false},{"name":"FMEA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false},{"name":"OPC UA","optional":false},{"name":"SolidWorks","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-11-04T18:56:04Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-09T13:33:54Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Location: Onsite\nStatus Type: Full Time\nQUALIFICATIONS\nRequired:\nBachelor’s degree in Mechanical Engineering from an accredited university.\nA minimum of 8 years of manufacturing engineering experience in a regulated industry (medical device, pharmaceutical, or similar).\n\nA minimum of 6 years of experience participating in validation and qualification activities for manufacturing equipment and processes.\n\nProven hands-on experience in the design, integration, and implementation of highly automated assembly lines, including robotics, motion control, and inspection systems.\n\nDemonstrated experience collaborating with cross-functional project teams and automation suppliers.\n\nExperience with high-volume manufacturing (1M+ units annually, less than 10-second cycle time).\n\nStrong hands-on experience with automation controls and programming, including Allen-Bradley Programmable Logic Controllers (PLCs), Human Machine Interfaces (HMIs), Supervisory Control and Data Acquisition (SCADA) systems, and data acquisition networks.\n\nExperience with automated testing, vision inspection, and servo-driven motion platforms.\n\nDeep understanding of robotic systems (SCARA, Cartesian, and collaborative robots) and industrial networking protocols (EtherNet/IP, OPC-UA).\n\nExperience with cleanroom manufacturing (International Organization for Standardization (ISO) Class 8) and contamination control strategies.\n\nDemonstrated ability to optimize Overall Equipment Effectiveness (OEE), line efficiency, and equipment reliability using Total Productive Maintenance (TPM) and Reliability-Centered Maintenance (RCM) methodologies.\n\nStrong application of Lean manufacturing principles, including value stream mapping, Single-Minute Exchange of Die (SMED), and kaizen facilitation.\n\nPreferred:\nSix Sigma Black Belt (CSSBB) or Certified Manufacturing Engineer (CMfgE).\n\nProficiency with SolidWorks, Minitab, PLC programming software (e.g., Studio 5000/RSLogix), and Microsoft Office Suite.\n\nExperience with digital twin technologies or line simulation modeling for capacity and throughput analysis.\n\nKnowledge of Good Automated Manufacturing Practice (GAMP) 5, International Organization for Standardization (ISO) 13485, and Title 21 CFR Part 820 for equipment and software validation.\n\nRobot programming or integration experience with major platforms (e.g., FANUC, ABB, Epson) and/or vendor automation certifications.\n\nSkills & Competencies:\nProficient in equipment design, validation, and lifecycle management, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).\n\nAdvanced skills in process optimization, data analysis, and problem solving.\n\nEffective communicator with excellent technical writing and presentation skills.\n\nStrong skills in supplier management and technical coaching.\n\nDeep understanding of Lean Six Sigma, process capability analysis (Cp, Cpk, Ppk), and Measurement System Analysis (MSA).\n\nExperience facilitating kaizen events, Design of Experiments (DOE) studies, and Statistical Process Control (SPC) monitoring.\n\nUnderstanding of Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, and automation data connectivity for traceability and performance tracking.\n\nAdaptability and resilience in dynamic, high-volume manufacturing environments.\n\nAdvanced troubleshooting and optimization of PLC, HMI, and SCADA-based control systems supporting automated production equipment.\n\nSkilled in robot programming, motion control tuning, and vision system calibration for automated assembly and inspection equipment.\n\nRESPONSIBILITIES:\nDesign, specify, and implement fully automated assembly and test equipment, including robotics, motion control, and vision inspection systems.\n\nProgram, configure, and troubleshoot PLCs, HMIs, SCADA systems, and robotic controllers supporting automated production lines.\n\nLead troubleshooting and continuous improvement efforts for automated equipment to enhance performance, quality, and reliability.\n\nExecute and support process validation activities (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) and documentation in compliance with Food and Drug Administration (FDA) and International Organization for Standardization (ISO) standards.\n\nDevelop and implement Standard Operating Procedures, training, and qualification documentation.\n\nSupport relationships with automation suppliers, participate in design reviews, and execute Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).\n\nDrive improvements in Overall Equipment Effectiveness (OEE), yield, and efficiency using Lean Six Sigma tools.\n\nProvide technical guidance and mentorship to engineers and technicians.\n\nDevelop and maintain Quality System documentation related to manufacturing processes and equipment.\n\nCollaborate with cross-functional teams to deliver automation and manufacturing engineering project goals on time and within budget.\n\nSupport risk management through Failure Mode and Effects Analysis (FMEA) and other preventive quality tools.\n\nPhysical Requirements:\nMust be able to remain in a stationary position for extended periods of time.\n\nAbility to constantly operate a computer and other office equipment, such as printer, telephone, etc.\n\nAbility to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time.\n\nPosition requires being physically present on the premises during regular company hours or as approved by management.","description_format":"text","description_chars":5542,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Contract Manufacturing","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-11-04T18:56:04Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":40,"reasons":["conf:3","win:early"],"computed_at":"2026-11-09T06:03:00Z"},"pay":null,"html_url":"https://alion.io/job/enable-injections-staff-engineer-manufacturing","json_url":"https://alion.io/job/enable-injections-staff-engineer-manufacturing.json","meta":{"generated_at":"2026-11-09T17:51:49Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per 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