Process Engineer I

Process Engineer I The Process Engineer I is responsible for understanding, optimizing, and sustaining manufacturing processes within a value stream leveraging lean and six sigma tools. The role develops end-to-end process understanding, addresses lifecycle management, and executes tactics in compliance with corporate policies and regulatory standards such as FDA, GMP, ISO 9001, ISO 13485, EU MDR, and Canadian Medical Device Regulations. Core Responsibilities Work cross-functionally with EHS, product development, process technology, Centers of Excellence, facilities, quality, regulatory, planning, and procurement to address process challenges and sustain changes. Represent value stream teams on strategic site and enterprise projects focusing on quality improvements, lifecycle management, and new product introductions. Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders, and Engineering Drawings for equipment and processes. Conduct statistical process control, trend analysis, and improvement of manufacturing yields and scrap. Perform technical investigations, non-conformance analyses, FMEA, and CAPA. Drive process, quality, reliability, and cost improvements using advanced technologies and lean six-sigma methodologies. Conduct time studies, process evaluations, and technical evaluations to align BOMs, work instructions, and routers with process for cost accuracy and product lifecycle. Monitor performance metrics and develop improvement actions to achieve targeted KPIs. Develop hands‑on product/process/equipment training programs. Participate in cross-functional project teams including product development, quality assurance, facilities, regulatory, and manufacturing. Qualifications Bachelor’s degree in Engineering or Science. 0–3 years of relevant experience. Tools & Systems General office equipment: Computers, printers, copiers, fax machines, telephone systems. Software and systems: ERP (e.g., SAP), CRM platforms, statistical analysis tools (Minitab/SPC), project management software (MS Project, Jira), QMS platforms (TrackWise), Microsoft Office Suite. Physical Requirements Work in manufacturing, cleanroom, laboratory, and office environments. Ability to sit, listen, speak, and move throughout the building. Travel across company locations as needed. Periodically lift or move items up to 25 pounds. Domestic and international travel by car, train, or airplane as required. Adverse Working Conditions Exposure to hazardous and biohazardous materials including flammable and corrosive liquids, compressed gases, sharps, and medical waste. Personal protective equipment provided and required. Compensation and Benefits Salary Pay Range: $62,100.00 – $85,100.00 USD. Eligible for bonus, commission, equity, or other variable compensation. Company-sponsored benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, and 401(k) savings plan. Equal Opportunity Employer 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. EEO is the law. Candidates with disabilities are encouraged to request accommodations. #J-18808-Ljbffr INTEGRA LIFESCIENCES CORP