Kalogon
Manufacturing Engineer
Melbourne, FL
Sponsorship not specifiedDetected 62 days ago
AuditingProcess ImprovementMedical Devices
About the role
- Role Details This is an on-site role at the Kalogon offices in Melbourne, FL.
- People with disabilities are encouraged to apply.
- If you require a disability-related accommodation for your application, please email us at careers@kalogon.com.
Responsibilities
- 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.
- 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>
Requirements
- 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.
- Experience with Lean and continuous improvement tools.
- 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.
- Familiarity with design for manufacturability (DFM) principles and experience collaborating with engineering on product and process changes.
- Role Details
- This is an on-site role at the Kalogon offices in Melbourne, FL.
Compensation
- 20 PTO days per year*
Benefits
- 8 holiday days (5 fixed and 3 floating)*
- 20 PTO days per year*
- Number of floating holidays and PTO vary based on start date during year.
- Own and implement manufacturing processes and systems that adhere to ISO 13485 for Class I Medical Devices.
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