The Staff 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 of 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.

These positions operate with increasing independence, technical depth, and leadership responsibility commensurate with level assignment.

CORE RESPONSIBILITIES (ALL LEVELS)

• 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 well as 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.
• 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 (as necessary) 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 Effects 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 (KPI's).
• 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.
• Complete other job-related duties as assigned.

STAFF PROCESS ENGINEER

• Provide strategic process engineering leadership for manufacturing operations and quality systems.
• Own and resolve high-risk, complex process issues with significant business or regulatory impact.
• Lead site-level or enterprise-level process improvement and compliance initiatives.
• Define best practices, standards, and methodologies for process engineering activities.
• Respond and resolve immediate escalations from manufacturing floor and escalate to leadership / appropriate parties as needed.
• Mentor Process Engineers and influence cross-functional teams without direct authority.

Education/Experience:

• Bachelor's degree in Engineering or Science
• 8+ years Process / Manufacturing Engineering experience in regulated manufacturing.
• Advanced certifications strongly preferred.

TOOLS & SYSTEMS

• 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 (e.g., TrackWise), statistical analysis tools (Minitab/SPC), Microsoft Office Suite.

PHYSICAL REQUIREMENTS

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to:

• Work in manufacturing, cleanroom, laboratory, and office environments.
• Sit, listen, speak, and move throughout various areas of the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty-five pounds.
• Travel domestically and internationally via car, train, or airplane, as required by the role.

Salary Pay Range:

$109,250.00 - $149,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences