Manufacturing Engineer

Kalogon

MELBOURNE, FL

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JOB DETAILS

SKILLS

Analysis Skills, Assembly Line, Change Order Management, Clinical Research, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Documentation, Engineering Change Order, Facilities Management, Field Trials, ISO (International Organization for Standardization), Lean Manufacturing, Manufacturing Assembly, Manufacturing Audit, Manufacturing Engineering, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Process Improvement, Product Design, Quality Assurance Methodology, Quality Metrics, Requirements Management, Return Merchandise Authorization (RMA), Root Cause Analysis, Standard Operating Procedures (SOP), eCos

LOCATION

MELBOURNE, FL

POSTED

2 days ago

Kalogon is a trusted leader in seated health, driven by clinical research, deep customer empathy, and rapid product iterations to meet customer needs. We build advanced seating technologies for people who must sit enhancing comfort, protecting health, and improving outcomes. Responsibilities 1. Product Improvement for Manufacturability - Design and implement product changes with a focus on rework rates, cost, and assembly time, utilizing direct feedback from production technicians and field feedback to validate improvements and surface further opportunities. - Lead root cause analysis for defects and non-conformances, driving corrective and preventive actions (CAPA) to resolution and verifying effectiveness. - Manage analysis and disposition of units returned through the Return Authorization (RA) process, ensuring root cause is identified, findings are documented, and systemic corrective actions are driven when required. 2. Process Improvement and Waste Reduction - Apply Lean and continuous improvement methodologies to evaluate and refine manufacturing processes, building quality into operations rather than inspecting it at the end. - Manage engineering change orders (ECOs) for existing product lines. - Analyze SOPs, assembly workflows and production training to optimize the efficiency of manufacturing processes and ensure consistent quality parts. - Manage facility upgrades for new equipment, including evaluating equipment requirements, assessing current facility utilities, coordinating contractors' quotes, and overseeing installation./li> 3. Quality Assurance and Process Compliance - Own and implement manufacturing processes and systems that adhere to ISO 13485 for Class I Medical Devices. - Conduct regular spot checks and audits across the manufacturing line to verify conformance to process documentation, work instructions, and quality standards. Benefits: - 8 holiday days (5 fixed and 3 floating)* - 20 PTO days per year* - 401K with matching - Equity *[Number of floating holidays and PTO vary based on start date during year.]* Kalogon is an E-Verify employer. People with disabilities are encouraged to apply. If you require a disability-related accommodation for your application, please email us at careers@kalogon.com.

About the Company

Kalogon

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