Senior Process Engineer I

Position Overview

The Sr. Process Engineer is responsible for understanding, optimizing, and sustaining manufacturing processes within a value stream. Leveraging lean and Six Sigma tools, the engineer improves processing, layout, workflow, assets, assembly methods, and workforce usage to increase process efficiency. The role requires end‑to‑end process and product understanding, control, and lifecycle sustaining engineering changes in compliance with corporate policies and regulatory requirements such as FDA regulations, GMP, ISO 9001, ISO 13485, EU MDR, and the Canadian Medical Device Regulations.

Key Responsibilities

• Develop a cross‑functional network with EHS, product development, process technology, Centers of Excellence, facilities, quality, regulatory, planning, and procurement to address process challenges, lifecycle and sustaining changes.
• Represent value stream teams in strategic site and enterprise projects on cross‑functional teams addressing quality improvements, lifecycle management, 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, analyze and trend existing process parameters, inputs, and outputs, improve manufacturing yields, reduce scrap, and error‑proof manufacturing processes.
• Perform technical investigations, non‑conformance analysis, Failure Mode Effects 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 and lean Six Sigma methodologies.
• Ensure value stream BOMS, routers, and work instructions align with processes and maintain cost accuracy throughout product lifecycle.
• Complete process improvement actions to achieve targeted Key Performance Indicators (KPIs).
• Develop hands‑on product, process, and 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.

Skills & Competencies

• Minimum Bachelor’s degree in engineering or equivalent with 5+ years of experience; Master’s degree acceptable with 3+ years of experience.
• Experience with statistical process control tools such as SPC and Minitab.
• Lean Six Sigma experience required.
• Excellent organizational and communication skills (oral and written).
• Strong interpersonal and employee development skills.
• Project management experience; PMP certification desirable.
• Knowledge of enterprise resource planning, material resource planning, and MS Office.

Tools and Equipment Used

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

Physical Requirements

• 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 by car, train, or airplane as required.

Adverse Working Conditions

• Exposure to hazardous and biohazardous materials such as flammable and corrosive liquids, compressed gases, sharps, and medical waste.
• Use of appropriate safety protocols and personal protective equipment (PPE) is required and provided.

Disclaimer

The responsibilities and duties described are intended to illustrate the general nature and level of work performed by individuals in this position. They do not represent an exhaustive list; additional duties may be assigned as needed.

Salary Pay Range

$71,000.00 – $98,000.00 USD per year. Pay is determined by role, level, location, skills, experience, and education. Additional variable compensation (bonus, commission, equity) may apply.

Benefits

• Medical, dental, vision, and life insurance.
• Short‑term and long‑term disability coverage.
• Business accident coverage and legal insurance.
• 401(k) savings plan.

EEO Statement

Integra LifeSciences 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. Individuals with disabilities or veterans may request reasonable accommodations in accordance with the ADA.