Manufacturing Engineer

Experience Required: 3 to 7 years

Responsibilities

• 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.
• 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.
• Quality Assurance and Process Compliance
• Own and implement manufacturing processes and systems that adhere to ISO 13485 for Class I Medical Devices.
• Maintain the Quality Management System (QMS) with findings, corrective actions, and improvements, ensuring timely and accurate documentation.
• 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.