Senior Manager, Manufacturing Engineering

Senior Manager, Manufacturing Engineering

Location: Onsite Status Type: Full Time

Qualifications Required: 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).

Preferred: 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.

Skills & Competencies: 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.)

Physical Requirements: 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.

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.

Nearest Major Market: Cincinnati