Enable Injections, Inc. · 5 hours ago
Manager, Manufacturing Engineering
Cincinnati Metro
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expEnable Injections, Inc. is seeking a Manager of Manufacturing Engineering to lead the design and development of manufacturing processes for medical devices. The role involves managing direct reports, ensuring compliance with regulatory requirements, and driving process improvements in a high-performance team environment.
Medical DeviceHealthcareManufacturingLife ScienceHealth Care
Responsibilities
Lead and develop direct reports such as manufacturing engineers; set clear expectations, provide regular feedback, and cultivate a high-performance, accountable team culture
Model and reinforce a positive, action-oriented attitude that encourages ownership, collaboration, and constructive problem-solving
Lead the design and development of manufacturing processes, including equipment specification, design, development, construction, implementation and modification
Review and Approval of manufacturing process documentation, drawings, NCR’s, CAPA’s and other quality documents
Creation of manufacturing process and equipment development documentation
Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements
Create test protocols to challenge equipment performance against intended specifications
Execute protocols and write validation reports
Process Validation to meet regulatory requirements which includes writing protocols, execution of the protocol, and writing the validation report
Standard Operating Procedures creation, revision and implementation including necessary change order, training and verification activities
Test Methods write and execute test method validations such as Gauge R&R studies
Project Management prepares overall project proposals including cost estimates and schedules for designated projects
Assign priority and schedule tasks to provide timely solutions to achieve results
Participate as a member of or facilitate cross functional teams
Support troubleshooting equipment downtime and identifying short term and long-term repairs/ short stop mitigations
Apply engineering principles and methods to understand and provide solutions to complex technical challenges
Continuously evaluate team performance and processes to identify opportunities for improvement and increased effectiveness
Other duties as assigned
Qualification
Required
Bachelor's Degree in a technical discipline (e.g. Engineering or Science) and/or education/experience equivalent
A minimum of 10 years of experience in process design and development to support new product development
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
Experience with Product DFMA (Design for Manufacturing and Assembly)
Preferred
Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual
Experience with custom equipment design, procurement and qualification such as via the GAMP process
Experience in reviewing production floor/ equipment downtime, including troubleshooting and identifying robust corrective actions, equipment continuous improvement
Experience programming vision systems, robotics, and PLC
Six Sigma Green Belt (or higher) Certification (CSSGB)
Excel and Minitab
SolidWorks
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.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$352MKey Investors
SanofiMagnetar CapitalORI Capital,Sanofi
2026-01-06Corporate Round· $30M
2022-01-27Series C· $215M
2020-09-08Debt Financing· $25M
Leadership Team
Mike Hooven
President and CEO
Tim Flaherty
Executive Vice President , Chief Financial Officer
Recent News
Medical Product Outsourcing
2026-02-08
2026-01-22
Company data provided by crunchbase