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.
- 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 Details
- 8 holiday days (5 fixed and 3 floating)*
- 20 PTO days per year*
- 401K with matching
- Equity
This is an on-site role at the Kalogon offices in Melbourne, FL.
Benefits:
*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 [email protected].
Skills Required
- Bachelor's degree in Engineering, Manufacturing Engineering, Industrial Engineering, or related field
- 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
- Experience with Lean and continuous improvement tools
What We Do
Kalogon is a venture-backed small business based in Melbourne, Florida, founded by top engineering talent from SpaceX and NASA. Our mission is to eliminate the stresses of sitting and improve health through inventive seating solutions. Kalogon’s flagship medical product is a customized smart cushion, Orbiter Med, that relieves pain and fatigue experienced by individuals who use wheelchairs. We have three other products in the medical space: Bondar (back support), Booster (smart cushion accessory), and our original Orbiter (smart cushion). Beyond healthcare, we’re expanding into defense and aviation with three U.S. Air Force Direct to Phase II SBIR contracts to design custom seating for B-52 and E-4B aircrew, and a commercial aviation proof of concept. Kalogon is a fast-paced company that leverages lean startup methodology to rapidly improve our technology in close partnership with our customers and partners. At the core of our approach is empathy-driven design, ensuring that we deeply understand the challenges our users face and create solutions that directly address their needs, enhancing both comfort and quality of life.
