Responsibilities1. 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.
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.
Role DetailsThis is an on-site role at the Kalogon offices in Melbourne, FL.
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.
