Engineering Project Manager Napoli

Engineering Project Manager
Napoli
Campania, Napoli

About the Company Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care. Here at Lenkbar, we give our customers the competitive edge in today's highly specialized design and development of cutting tools. We assist with the design and production of a variety of drills, burrs, and taps for the orthopedic industry and world-class flexible shafts to meet our customers' most demanding requirements. From Swiss turning to precision grinding, we leverage advanced machining techniques and best-in-class equipment that are automated and optimized for performance to support our customers' next critical product launch. Position Summary: Plan and implement technical engineering solutions; perform a variety of manufacturing support activities as necessary for efficient production of high-quality parts; provide business and technical leadership for major site projects. Essential Duties and Responsibilities: Manage and execute assigned projects from the Engineering Manager. Ensure accountability for overall program and project performance including integration of project activities, liaison for senior management, R&D and other stakeholders, project resources, and financial achievement. Provide business and technical leadership for major site projects, process improvements, supplier change notices, capacity expansions, and facility upgrades. Provide input to the program prioritization process and participate in other key strategic business portfolio processes. Provide clear direction on project requirements to meet expectations of customers and stakeholders. Manage project timelines to ensure on-time delivery of simultaneous projects. Coordinate and participate in reviews of customer specifications and product designs for compliance with engineering principles, company standards, and quality standards. Review customer/project requirements, specifications, and schedules to determine needed support activities. Communicate all identified clarifications and exceptions to the customer and obtain approval. Lead the team in defining program strategies, developing goals, assigning project tasks, and ensuring the team meets all goals. Direct integration of technical activities and products with internal and external resources. Prepare interim and completion project reports and presentations for periodic communications with project team members and management team. Provide engineering support functions. Interact with all levels of management for program updates and reviews. Set the program strategy, schedules, resource alignments, and financial analysis. Approve team deliverables for project completion. Provide project management technical expertise in all phases of project execution. Develop and implement process flows as needed. Perform reviews of customer orders and determine processing requirements to produce cost-effective conforming components and assemblies. Develop manufacturing processes and routers that are consistent with customer (Quality agreement) and BMI operating procedures and work instructions through analysis of application, research, design, modification, and testing of manufacturing methods and equipment. Coordinate testing protocols working with R&D and the engineering team. Evaluate and improve manufacturing processes to support customer and BMI requirements by working closely with production; designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials. Participate in vendors' evaluation and engineering management of them. Coordinate ME's, QE's with a range of machine and process validation activities as needed (IQ, OQ, PQ). Participate in design reviews with the RD team and customers, validation process, and continuous improvement activities. Manage the manufacturing processes for new orders from concept to production. Guarantor of processes within the company. Perform time studies in the plant and in turn develop continuous improvement initiatives. Partner with the programming department to develop/design custom tooling that would be required for machining, or purchase tooling as required. Review subcontractor processes for efficiency and challenge the process when needed; participate in audits as needed. Assist with the quoting process. Process owner to improve Epicor utilization for the manufacturing engineers. Identify and justify new equipment reflective of process improvements. Lead and support the CAPA and Complaint processes to ensure timely closure, for engineering, subcontracting, or manufacturing subjects. Facilitate team meetings to actively manage the planning process for new projects. Act as engineering point person to assist plant personnel when issues arise. Assist with leading and developing the engineering team. All other duties as assigned. Knowledge, Skills & Competencies: Min of 7 years of related experience in Manufacturing Engineering in a machining production, design facility. Experience participating in and managing process improvement projects within a regulated manufacturing environment. High level of project planning proficiency; ability to effectively manage multiple projects. Certified Project Management Professional or ability to obtain such is preferred. Experience in medical device manufacturing environment. Experience with planning, developing, and conducting tests to validate machine and secondary processes. Thorough understanding of raw materials, manufacturing processes, and quality control practices. Knowledge of CNC machining, tooling, processes, and machining capabilities. Knowledge and understanding of blueprints and GD&T a plus. Experience in ISO 13485 /FDA 21 CFR820. Prior experience with CAPAs and complaints a plus. Ability to understand the technical attributes of a wide range of precision, mechanical products. Critical thinking skills and ability to identify complex problems and review related information to develop and evaluate options and implement solutions. Ability to communicate effectively in a multi-discipline, cross-cultural environment and levels of organization. Ability to work in a team environment, as well as autonomously. Capable of handling stressful situations and manage conflict. Ability to read and comprehend complex instructions. Maintain sense of urgency and ability to prioritize work. Computer literate in various software applications (i. e. Microsoft Office). Experience leading a team of engineers. Understanding of Lean Manufacturing and/or 6 Sigma. Strong customer service and communication skills with both internal and external customers. Job Posted by ApplicantPro J-18808-Ljbffr