Company Overview:

CAIRE is a global engineering solutions and medical device company providing leading oxygen related products to the Healthcare and Industrial/Commercial markets. We support customers in over 100 countries and have operating facilities in the US, Germany, UK, Italy, Japan and China.

In 2018 CAIRE joined NGK/NTK, a global industrial spark plug company with a growing healthcare and environmental portfolio of products. CAIRE is a wholly owned subsidiary of NGK/NTK but operates predominately as an independent company with headquarters just north of Atlanta in Ball Ground, Ga. Read more CAIRE news at www.caireinc.com.

JOB DESCRIPTION

The Manufacturing Engineer is responsible for the development, implementation, improvement, and support of the manufacturing processes for Caire. The individual must be performance driven, hands on, have technical understanding and organizational skills. Responsibilities include but are not limited to process capability analysis, conducting process qualifications and validations, tooling design, and process cycle time/lean manufacturing. The Manufacturing Engineer will need to have a working understanding of process characterization tools and be able to leverage them across different technologies.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Evaluate production processes, analyze efficiencies, and develop improvements to drive productivity.
• Assess process capabilities and apply technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Personally, conduct and/or supervise studies to determine cause, effect and the corrective measures required to remedy deviations that compromise desirable quality standards.
• Interface with various departments in defining and providing solutions to identified manufacturing processes contributing to quality problems.
• Identify product assembly issues and work with production, engineering, and maintenance to resolve issues and improve product consistency and eliminate variance.
• Independently analyzes and solves engineering problems
• Troubleshoot production assembly and component issues, both mechanical and electronic components.
• Design, develop, and/or maintain new and existing fixture and jig solutions that support daily production, promote error proofing, ergonomics, and safety.
• Develop and refine fabrication and assembly processes.
• Review and audit BOMs, work instructions, production components/items, and employee activities to ensure they all adhere to established standards.
• Capable of making recommendations and managing capital equipment project improvements
• Manage multiple projects and product lines effectively.
• Trains and/or provides work direction to operators and may train manufacturing personnel when required
• Monitor production processes and work with production personnel to create standard work procedures, enhance flow, and implement lean concepts throughout the plant.
• Responsible for reviewing and auditing activities of the production operators and supervisors on the production floor
• Inform and orient employees to specific procedures, processes, and objectives of operational departments, stressing and promoting quality, safety, and company policies
• Promotes improvement through problem solving techniques, 5S, and other lean manufacturing processes.
• Apply Lean and six sigma principles to production processes
• Work closely with team members to identify and eliminate waste activities.
• Ensures proper documentation to satisfy quality systems requirements. (e.g., BOM's, Routers, IQ/OQ/PQ, PFMEA’s, etc.)
• Plan and conduct process qualifications & validations.
• Supports compliance with all international, federal, state, and local regulatory requirements, including, but not limited to FDA, ISO, OSHA and hazardous waste handling
• Perform periodic final inspections at each production cell to ensure product quality is aligned with company standards.
• Collaborate with the design engineering group to ensure that all aspects of new product introduction and changes to existing products are properly communicated to production personnel. Communicate the ECR/ TDD changes to production.
• Key contributor into the NCR process
• Other duties and responsibilities as assigned by management

Competencies

• Lean manufacturing experience
• Strong technical, written and verbal communication skills
• Strong organizational and interpersonal skills
• Collaboration and communication efficiency
• Project management
• Problem solving and analysis
• Business acumen
• Teamwork orientation & leadership

Supervisory Responsibility

May have management responsibilities

Work Environment

This job operates in a professional office environment and manufacturing/distribution environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This is largely a physically active role. This would require the ability to lift, bend, or stand as necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel

May require up to 10% travel. Some travel may be international.

Required Education and Experience

• B.S or M.S or equivalent in relevant engineering discipline.
• 5+ years manufacturing experience working within a regulated industry
• Must be detail-oriented, a team player and possess excellent communication skills.
• Familiar with ISO 9001/13485 and GMP requirements.

Preferred Education and Experience

• Medical device experience preferred.
• Manufacturing engineering experience a plus.
• Experience in performing engineering duties with a “hands on” approach.
• Effective at planning, organizing and executing tasks.
• Formal lean six sigma training preferred.