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Enable Injections, Inc. · 2 weeks ago

Senior Production Engineer, Manufacturing

Cincinnati Metro

Full-time

Onsite

Senior Level

6+ years exp

Enable Injections, Inc. is a company focused on manufacturing medical devices. They are seeking a Senior Production Engineer to lead manufacturing support, continuous improvement initiatives, and quality system documentation in a regulated environment.

Health CareLife ScienceManufacturingMedical Device

Responsibilities

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

Continuous Improvement: Identify opportunities to improve yield/throughput/labor and independently lead implementation

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: Lead product/process/equipment investigations with cross-functional teams

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

Engineering Builds: Lead equipment/process development builds and tests; write protocols and engineering reports to summarize activities

Training: Act as approved trainer and mentor for manufacturing operators and junior engineers

Layout/Workflow: Independently determine and lead optimization of layouts and workflows using lean methodologies

Other duties as assigned

Qualification

FDA regulated manufacturingMedical device manufacturingLean Six Sigma CertificationAutomation technologiesStatistical techniquesCAD design (SolidWorks)Problem analysisAttention to detailVerbal communicationTechnical writingTeamworkCollaborationTime management

Required

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

Minimum of 6 years of experience in FDA regulated manufacturing and/or process/equipment/product development

Strong 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 (LSSGB/LSSBB)

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