Process Engineer II

Process Engineer

The Process Engineer is responsible to understand, optimize, and sustain manufacturing processes within a value stream leveraging lean and six sigma tools and methodologies to improve processing, layout, workflow, assets, assembly methods, and workforce usage to process efficiency. They develop end-to-end process and product understanding and control and address lifecycle management and sustaining engineering changes. They execute their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

• Work cross-functionally with EHS, product development, process technology, Centers of Excellence (CoE’s), facilities, quality, regulatory, planning, procurement to address process challenges, material changes, and lifecycle and sustaining changes.
• Represent value stream teams in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.
• Lead and execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
• Conduct statistical process control analysis and trending of existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
• Perform timely technical investigations, non-conformance, Failure Mode Effect Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Complete projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
• Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with process to ensure cost accuracy from product transfer through product lifecycle.
• Monitor performance metrics for value stream(s) and develop improvement actions necessary to attain targeted performance Key Performance Indicators (KPIs).
• Develop hands‑on product/process/equipment training programs.
• Participate in cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
• Respond to immediate escalations from manufacturing floor and escalates to leadership, as needed.
• Complete other job‑related duties as assigned.

• Bachelor’s degree in engineering or equivalent with 2‑6 years of experience.
• Statistical process control tools (SPC, Minitab, other software) desired.
• Lean Six Sigma experience desired.
• Excellent organizational and English communication skills (oral & written).
• Positive, sound interpersonal, and employee development skills.
• Project management and process improvement experience desired.
• Validation and requalification experience desired.
• Cleaning validation experience is a plus.
• Knowledge in MS Office skills.

• General office equipment:
  Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., SAP), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made. The employee is expected to sit, listen, speak, and move throughout various areas of the building; travel across all company locations as needed; periodically lift or move items up to twenty-five…