Note: The job is a remote job and is open to candidates in USA. Integra LifeSciences is dedicated to innovating new treatment pathways to advance patient outcomes in healthcare. The Process Engineer II is responsible for optimizing and sustaining manufacturing processes using lean and six sigma methodologies, ensuring compliance with various regulatory standards, and collaborating cross-functionally to address process challenges and improvements.
Responsibilities
- 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 processes 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
Skills
- Bachelor's degree in engineering or equivalent with 2-4 years of experience
- Statistical process control tools desired (SPC, Minitab, other software)
- Demonstrate excellent organizational and English communication skills (oral & written)
- Positive, sound interpersonal, and employee development skills
- Project management and process improvement experience desired
- Knowledge in MS Office skills
- Experience in managing multifunctional teams including EHS, Quality, Process Development, Planning and Materials Engineers
- Worked with global teams on enterprise projects to address quality improvements, lifecycle management plans, and NPI
- Executed material change validations
- Minimum of 2 years managing validation cycles (FAT, IQ, OQ, PQ TMV), engineering studies and documentation changes
- Proven experience in process monitoring(SPC) and improvements of KPI's with the use of Statistical Tools, and Lean Six Sigma Tools
- Performed Technical investigations, NC and CAPA's
- Lean Six Sigma Experience Preferred
- Preferred experience with time studies
- Preferred experience with Design of Experiments (DOE)
- Preferred Basic knowledge in automation, programming, sensors, and Vision systems
- Basic Project Management skills
- Good communication skills in both Spanish and English
- Good Technical writing skills
Benefits
- 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](https://www.integralife.com/careers/total-rewards)
Company Overview