Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Senior 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, 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. **Responsibilities** + Works within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes used to manufacture surgical products for the medical device industry. + Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment. + Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of lntegra products. + Support and guide transfers internally within plant and externally with suppliers. + Writes and implements Manufacturing Procedures and Work Instructions. + Creates, updates and maintains BOMs, Routers, and DMRs. + Works as a recognized manufacturing and process technical expert who can provide process engineering knowledge and oversight to resolving manufacturing-related problems with existing products and processes. + Champions improvement processes for rework, scrap, and labor variance reduction / elimination in the plant processes. + Supports Material Review Board process by investigating and resolving manufacturing and supplier quality concerns. + Identifies and provides innovative new manufacturing technologies from industry best practices that can be applied to lntegra products and manufacturing processes. + Represents the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing. + 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. **Skills & Competencies** + Bachelor's degree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required. + A minimum of 5 years of engineering industry experience is required. + Experience in the medical device industry is required. + Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required. + Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly is required. + Working kn