Posted July 28, 2026
Senior Manager, Manufacturing Engineer - 1st
Kable Workforce Solutions
Cincinnati, OH, US
Full Time
Job Description
Job Description
Location: Sharonville, OH
Employment Type: 1st Shift, Full-time, Direct hire
Employment Type: 1st Shift, Full-time, Direct hire
Job Brief
Kable Workforce Solutions is hiring a Senior Manager, Manufacturing Engineer for our client. This role is responsible for leading the Manufacturing Engineering team in the design, development, validation, and continuous improvement of manufacturing processes and equipment.
Kable Workforce Solutions is hiring a Senior Manager, Manufacturing Engineer for our client. This role is responsible for leading the Manufacturing Engineering team in the design, development, validation, and continuous improvement of manufacturing processes and equipment.
What’s a Typical Day Like?
- 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
What Are the Requirements of the Job?
- 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)
- 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
- 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.)
- Must be able to remain in a stationary position for extended periods of time (desk work).
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
- Ability to work in fast-paced environment.
- Ability to move or lift up to 50+ lbs.
- Ability to reach, grasp, hold, push, pull, bend, twist, squat, climb, kneel.
- Ability to utilize hand/eye coordination.
- Capability to stand for prolonged periods of time
How to Apply And Next Steps?
Please submit your resume in our application by clicking “apply now.” We look forward to reviewing your application and you will hear from us within 1 business day.
Please submit your resume in our application by clicking “apply now.” We look forward to reviewing your application and you will hear from us within 1 business day.
About Kable Workforce Solutions
For over 50 years, Kable Workforce Solutions has been connecting skilled professionals with leading employers across the region. We’re dedicated to helping people build lasting careers and helping companies grow through quality, integrity, and partnership.
For over 50 years, Kable Workforce Solutions has been connecting skilled professionals with leading employers across the region. We’re dedicated to helping people build lasting careers and helping companies grow through quality, integrity, and partnership.
We believe in people first — empowering individuals to succeed and celebrating the work that drives our communities forward.
Kable Workforce Solutions is proud to be an equal opportunity employer. We welcome and value diversity and are committed to creating an inclusive workplace where everyone can thrive. Read our full diversity statement here.
This job description is not intended to be all-inclusive, and the employee will also perform other reasonably related business duties as assigned by the immediate supervisor and other management as required.
