Responsible for meeting internal and external customer manufacturing requirements for the new product launch of surgical instruments and implants through robust process design. The position will participate in a customer focused team facilitating all activities associated with a product launch between the customer, supply chain, and company. The position will also be responsible for leading continuous improvement activities on legacy products by implementing the latest manufacturing technologies to advance throughput, quality, and compress costs. The position will initiate and engage in projects across all locations within the organization requiring extensive travel. (up to 80%)
- Supports project requirement checklists through justification and/or rationalization of activities associated with new product launch or legacy product re-engineering.
- Leads process and product transfer activities between divisions ensuring best practices are communicated and adhered to.
- Leads or support process improvement initiatives
- Introduce new processes, products, and equipment to advance corporate manufacturing technology portfolio.
- Leads in the specification of new equipment requirements and manages all aspects of installation and process development.
- Develops and monitors timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
- Understands all current CNC manufacturing processes and identifies targets for improvement in transactional and operational efficiencies.
- Designs, develops, tests, sources, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.
- Investigates, present to leadership, and implements engineering software advancements and best practices as it relates to CNC manufacturing and process design.
- Assist in the development and deployment of advanced CNC post processors for NX, MasterCam, and Partmaker softwares.
- Leads engineering evaluations of manufacturing tooling and fixtures for areas of improvement.
- Redesign CNC fixtures and tooling, driving towards automation to replace manual processes and increase OEE.
- Creates manufacturing work instructions to communicate process and equipment knowledge.
- Monitor manufacturing performance using quality and statistical tools.
- Leads engineering test protocol development and reporting for process characterization and process testing.
EXPERIENCE / EDUCATION:
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or other appropriate engineering or engineering technology discipline highly preferred or the equivalent years of work experience.
- Minimum of 7 years of experience in engineering to include the development of new processes, new products, product costs, cost reductions, capital justifications, and capital equipment acquisition and deployment.
- Materials experience/knowledge with manufacturing using titanium, cobalt chrome, stainless steels, medical grade plastics, etc.
- In depth process experience/knowledge with advanced CNC machining of metals and plastics (e.g. sliding and fixed head lates, vertical and horizontal multi-axis mills, wire and sinker EDM, multi-axis grinding, and multi-tasking centers.)
- Minimum of 5 years experience with tight tolerance methods in machining and measurement system applications, complete understanding of detailed blueprint reading and Non-Recurring Expenses (NRE), GD&T, working knowledge of short run process control methods, statistical analysis, design of experiment (DOE), ISO standards and FDA quality system regulations.
- Advanced experience with Fanuc, Siemens, and Haas CNC controls.
- Strong knowledge of programming standards and engineering practices, including Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO 13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic understanding of the human anatomy required.
- NX, Solidworks, Mastercam, Partmaker, etc.)
Travel Requirements:This position will require 75% or more travel to various manufacturing divisions both domestically and international with extended onsite support up to 6 months at a time.