Senior Manager, Manufacturing Engineering

Enable Injections Inc.•Sharonville, OH

2d•Onsite

About The Position

This role is for a Senior Manager of Manufacturing Engineering, responsible for leading the design and development of manufacturing processes and equipment. The position involves managing direct reports, delegating tasks, and ensuring alignment with corporate strategies. Key responsibilities include overseeing equipment qualification, process validation, and the creation and revision of standard operating procedures and test methods. The role also entails project management, including proposal preparation, cost estimation, and scheduling, as well as participation in cross-functional teams.

Requirements

Bachelor’s Degree in a technical discipline (e.g., Engineering or Science) and/or education/experience equivalent
A minimum of 8 years of experience in process/equipment design and development to support new product development and manufacturing
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)
Leadership – ability to create a vision and motivate employees to strive to create that vision
Attention to detail
Strong influencing and negotiating skills
Excellent verbal communication and technical writing skills
Proficient with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
Understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation
Experience with the validation life cycle (planning, protocol writing, execution, report writing)
Understanding and application of Good Automated Manufacturing Practice (GAMP)
Proficient with the MS Office Suite (Word, PowerPoint, Excel, etc.)

Nice To Haves

Experience in a high-volume manufacturing environment preferred, i.e., production 1M+annual, cycle time < 1 second
Experience with custom equipment procurement and qualification such as via the GAMP process

Responsibilities

Lead direct reports such as manufacturing engineers
Delegate and prioritize tasks to align with corporate strategies
Lead the design and development of manufacturing processes and equipment
Review and approve manufacturing process documentation
Creation of manufacturing process 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
Write protocols, execution of the protocol, and write the validation report
Standard operating procedures create, revise, and implement including necessary change order, training, and verification activities
Test methods, write and execute test method validations such as Gauge R&R studies
Project management, prepare overall project proposals including cost estimates and schedule for designated projects
Assign priority and schedule tasks to provide timely solutions to achieve results
Participate in cross functional teams
Other duties as assigned