Senior Engineer, Manufacturing - 1st

Job Description

Job Description

Location: Sharonville, OH
Employment Type: 1st Shift, Full-time, Direct hire

Job Brief
Kable Workforce Solutions is hiring a Senior Engineer, Manufacturing for our client. This role is responsible for equipment design, process validation, troubleshooting, project management, and providing technical leadership to engineering teams while ensuring compliance with quality and regulatory standards.

What’s a Typical Day Like?

• Manufacturing equipment specification, design, development, construction, implementation, or modification
• Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and/or the modification of part/mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes
• Assist in Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements
• Standard Operating Procedures creation, revision and implementation including necessary change order, training and qualification activities
• Apply engineering principles and methods to understand and provide solutions to complex technical challenges
• Identify and coordinate activities with outside suppliers and consultants as required. Interface with and select suitable vendors for the procurement of equipment
• Provide DFM and DFA guidance for development of robust product design in collaboration with Product Development
• Develop test methods and fixtures to prove functionality of sub-assemblies and final product. Select appropriate test methods and analyze test data to challenge the effectiveness of assembly equipment and processes
• Prepare overall project proposals including cost estimates and schedule for designated projects. Assign priority and schedule tasks to provide timely solutions to achieve results
• Resolve internal and external (customer or supplier) issues related to manufacturability and performance of product
• Maintain and repair equipment
• Delegate tasks to technicians and co-ops within the department
• Participate in cross functional teams and ideation sessions
• Work with functional managers and partners to ensure project goals are met
• Provide technical guidance and coaching of other engineers
• Contributes to project planning and execution to meet schedule and budget requirements
• Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms

What Are the Requirements of the Job?

• Bachelor's Degree in Mechanical, Industrial, Biomedical, or related Engineering, or equivalent experience.
• Minimum of 6 years of manufacturing engineering experience in a regulated industry such as Medical Device, Pharmaceutical, or Food Manufacturing (Master's degree with 4+ years considered).
• Experience with manufacturing equipment design, process development, equipment qualification (IQ/OQ/PQ), and process validation.
• Knowledge of medical device manufacturing processes, including automated assembly, welding, leak testing, vision systems, robotics, and PLCs.
• Experience with SolidWorks, Minitab, Microsoft Office, and technical documentation preferred.
• Understanding of FDA Quality System Regulations (21 CFR 820), GAMP, and validation protocols.
• Strong troubleshooting, analytical, and problem-solving skills with the ability to improve manufacturing processes.
• Excellent project management, technical writing, communication, and cross-functional collaboration skills.
• Demonstrated leadership, coaching, and the ability to manage multiple projects in a fast-paced manufacturing environment.
• Ability to work independently while adapting to changing priorities and business needs.
• 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.

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.

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.

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