Manufacturing Engineer
Melbourne, FL - USA
Job Summary
- 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.
- 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>
- 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.
- Bachelors degree in Engineering Manufacturing Engineering Industrial Engineering or related field (or equivalent practical experience).
- 37 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.
This 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.
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 emailprotected.
Required Experience:
IC
About Company
Kalogon delivers quality medically-validated seated health through customized, connected, and dynamic seating experiences, starting with wheelchair users.