Senior Process Engineer

The Senior Process Engineer is responsible for understanding, optimizing, and sustaining 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 enhance process efficiency. The role focuses on end‑to‑end process and product understanding, lifecycle sustaining engineering changes, and ensuring compliance with corporate policies and regulatory requirements (FDA, GMP, ISO 9001, ISO 13485, EU MDR, Canadian Medical Device Regulations, and others).

• Develop a cross‑functional network with Environmental, Health & Safety (EHS), product development, process technology, Centers of Excellence (CoEs), facilities, quality, regulatory, planning, and procurement to address process challenges, change requests, 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, and new product introductions.
• Initiate, develop, and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
• Leverage statistical process control (as necessary), analyze and trend existing process parameters, inputs and outputs, improve manufacturing yields, reduce scrap, and error‑proof manufacturing processes.
• Perform timely technical investigations, non‑conformance, Failure Mode Effect Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements using advanced technologies, lean Six Sigma tools, and methodologies.
• Ensure value stream(s) BOMS, routers, and work instructions align with process requirements and maintain cost accuracy from product transfer through product lifecycle.
• Complete process improvement actions to ensure performance metrics meet targeted Key Performance Indicators (KPIs).
• Develop hands‑on product/process/equipment training programs.
• Lead cross‑functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job‑related duties as assigned.

• Bachelor’s degree in engineering or equivalent with 5+ years of experience;
  Master’s degree with 3+ years of experience.
• Experience with statistical process control tools required (SPC, Minitab, or equivalent software).
• Lean Six Sigma experience required.
• Excellent organizational and English communication skills (oral & written).
• Sound interpersonal and employee development skills.
• Project management and process improvement experience; PMP certification desired.
• Knowledge of enterprise resource planning, material resource planning, and Microsoft 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 to enable individuals with disabilities to perform these duties. 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 pounds, and travel domestically and internationally by car, train, or airplane as required.

• Handling hazardous and biohazardous materials such as flammable and corrosive liquids, compressed gases, sharps, and medical waste.
• Adherence to appropriate safety protocols and personal protective equipment (PPE) requirements.

Integra Life Sciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.