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Enable Injections, Inc. · 2 weeks ago

Production Engineer III, Manufacturing

Cincinnati Metro

Full-time

Onsite

Mid, Senior Level

4+ years exp

Enable Injections, Inc. is a company focused on manufacturing processes and technologies in the medical device sector. They are seeking a Production Engineer III to support manufacturing operations, lead continuous improvement initiatives, and ensure quality system documentation in a regulated environment.

Health CareLife ScienceManufacturingMedical Device

Responsibilities

Manufacturing Support: Respond rapidly to downtime events and support efforts to bring production back online as quickly as possible

Continuous Improvement: Identify opportunities to improve yield/throughput/labor and begin leading implementation with guidance

Quality System Documentation: Author documents such as NCRs, CAPAs, change controls, and rework instructions; present at cross-functional review boards; author/revise DCOs and routers in SAP

Root Cause Investigations: Support product/process/equipment investigations with cross-functional teams

Production Model: Create and maintain labor/capacity/yield models for manufacturing lines

Engineering Builds: Support development builds; write engineering reports to summarize builds

Build Protocols and Reports: Author build protocols and reports

Training: Act as approved trainer for manufacturing operators

Layout/Workflow: Participate in efforts to optimize layouts and workflows using lean methodologies

Other duties as assigned

Qualification

FDA regulated manufacturingMedical device manufacturingLean Six Sigma CertificationTroubleshooting techniquesAutomation knowledgeCADAutoCADTechnical writingAttention to detailVerbal communicationTeamworkCollaborationTime management

Required

Bachelor's Degree in a technical discipline (e.g. Engineering or Science) and/or equivalent education/experience

Minimum of 4 years of experience in FDA regulated manufacturing and/or process/equipment/product development

Beginning experience leading cross-functional teams, projects, and/or direct reports

Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing

Preferred

Experience in a high-volume FDA regulated commercial manufacturing environment

Lean Six Sigma Green or Black Belt Certification (LSSBB/GB)

Company

Enable Injections, Inc.

Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience.

Founded in 2010

Cincinnati, Ohio, USA

201-500 employees