Manufacturing Engineer - Lean & CAPA for Medical Devices

Rival; Melbourne (FL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

8 holiday days (fixed)

20 PTO days

401K with matching

Equity

Job summary

Kalogon in Melbourne, FL, is seeking a Manufacturing Engineer to improve manufacturability, lead CAPA, and drive lean initiatives on-site at our Kalogon facilities. The role focuses on reducing rework, optimizing costs, and shortening assembly times through data-driven improvements.

Responsibilities include root cause analysis, RA disposition, ECO management, and QA/compliance with ISO 13485 standards. Benefits include paid time off, holiday days, 401K with matching, and equity.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing Engineering, Industrial Engineering, or related field (or equivalent practical experience).
• 3–7 years of experience in manufacturing engineering, quality engineering, or a related production role.
• Strong knowledge of Quality Management Systems, process auditing, and manufacturing quality methodologies.
• Experience performing root cause analysis and driving CAPA to resolution.
• Familiarity with design for manufacturability (DFM) principles and experience collaborating with engineering on product and process changes.
• Experience with Lean and continuous improvement tools.

Responsibilities

• Design and implement product changes to reduce rework, cost, and assembly time.
• Lead root cause analysis for defects and CAPA to resolution.
• Manage disposition of units returned through the RA process and drive systemic corrective actions.
• Apply Lean and continuous improvement methodologies to refine manufacturing processes.
• Manage ECOs for existing product lines.
• Analyze SOPs, assembly workflows and training to optimize manufacturing efficiency and quality.
• Oversee facility upgrades for new equipment, including evaluating requirements, coordinating quotes, and installation.

Skills

Root cause analysis

CAPA execution

Lean & CI

Process auditing

Quality systems

DFM

Education

Bachelor’s degree in Engineering

Job description

Kalogon in Melbourne, FL, is seeking a Manufacturing Engineer to improve manufacturability, lead CAPA, and drive lean initiatives on-site at our Kalogon facilities. The role focuses on reducing rework, optimizing costs, and shortening assembly times through data-driven improvements.

Responsibilities include root cause analysis, RA disposition, ECO management, and QA/compliance with ISO 13485 standards. Benefits include paid time off, holiday days, 401K with matching, and equity.