Process Engineer

                                 Operations Floor Supervisor

Job Summary: The Floor Supervisor oversees daily production activities on the manufacturing floor to ensure safety, quality, and productivity targets are met in compliance with FDA, ISO 13485, and internal quality‑system requirements. This role leads operators, coordinates workflow, resolves production issues, and ensures that all documentation and processes meet regulatory standards.

Essential Functions:

• Supervises day‑to‑day operations across assigned production lines.
• Assigns work, balances labor, and adjusts staffing to meet schedule demands.
• Monitors production output, cycle times, scrap, and efficiency metrics.
• Ensures adherence to work instructions, SOPs, and validated processes.
• Supports start‑up, changeover, and shutdown activities.
• Enforces GMP, GDP, and cleanroom/controlled‑environment requirements.
• Ensures accurate completion of Device History Records (DHRs) and production documentation.
• Escalates and documents nonconformances; supports NCR investigations.
• Partners with Quality to address inspection failures, deviations, and process issues.
• Ensures operators follow proper inspection, handling, and traceability procedures.
• Be responsible for team member training and competency development, implementing initiatives to reduce employee turnover.
• Conducts performance feedback and support skill development.
• Promotes a culture of accountability, safety, and continuous improvement.
• Addresses attendance, behavior, and performance issues promptly.
• Enforces safety policies and ensure proper use of PPE.
• Conducts safety checks and support incident investigations.
• Maintains a clean, organized, and audit‑ready production area.
• Identifies bottlenecks, waste, and processes inefficiencies.
• Supports Lean, 6S, and Kaizen initiatives.
• Provides feedback to engineering on equipment, tooling, and processes improvements.
• Collaborate with Engineering, Quality, Supply Chain, and Warehouse to support NPI, process optimization, and material supply.
• Report production KPIs including output, efficiency, yield, cost, and quality.
• Ensure EHS compliance; eliminate safety risks and maintain a safe working environment.

 Qualifications:

• Associate degree or equivalent; Bachelor degree preferred.
• 3+ years of experience in manufacturing, ideally medical device, pharma, aerospace, or other regulated industries.
• 1+ year of leadership or lead‑operator experience.
• Strong understanding of GMP, ISO 13485, and FDA‑regulated production.
• Ability to read and interpret work instructions, SOPs, and basic technical drawings.
• Excellent communication, problem‑solving, and decision‑making skills.
• Ability to work on-site in a manufacturing environment.

Preferred but not required Qualifications:

• Experience supervising cleanroom operations.
• Familiarity with ERP/MES systems (SAP, Oracle, etc.).
• Knowledge of Lean Manufacturing tools (5S, root‑cause analysis, standard work).
• Experience supporting audits or regulatory inspections.

Competencies:

• Strong problem‑solving and critical‑thinking skills
• High attention to detail and documentation accuracy
• Ability to work cross‑functionally in a fast‑paced environment
• Commitment to patient safety and product quality
• Continuous improvement mindset

Physical and Work Environment Requirements:

• Ability to stand for extended periods.
• Manual dexterity for handling small components.
• Work in cleanroom or controlled‑environment areas as required.
• Occasional travel for supplier audits or training
• Ability to lift up to 40 lbs

Travel & Benefits

• Travel is approximately 10% with overnight stays required
• We offer a competitive base salary and benefits.