Job Description:
Employer: DJO, LLC, a subsidiary of Enovis Corporation
Job title: Manufacturing Engineering Manager
Job location: Vista, CA
Serve as department lead for the sustainment and improvement of the manufacturing process of Class I, II and III Medical Devices with knowledge and understanding of ISO 13485 and FDA regulatory requirements. Determine and coordinate cost saving projects for the manufacturing process. Define, update and control manufacturing documentation in alignment with QMS and regulatory requirements. Perform critical analysis of collected data to assess issues and determine course of action for their resolution. Perform material evaluation and testing for applications in the production of custom knee braces applying in-depth understanding of composite materials. Responsible for product costing, process optimization, and Lead NPI for manufacturing. Assist the R&D (Research and Development) department in the design of new products with a DFM (Design for Manufacturing) focus. Manage and develop a team of professional engineers and technicians. Prepare and manage the department budget. Collaborate with the management team and leadership to set and assess priorities across teams and development of the CAPEX plan.
Requirements:
Bachelor's degree or equivalent in Industrial Engineering, or a related field and six years of experience in the position offered or a related position. Must have six years of experience with the following: Utilizing Project Management tools, including Gantt Charts and Microsoft Project for the planning and tracking of projects related to the introduction of new products and processes; Utilizing Lean Manufacturing tools, including Value Stream Mapping, PDCA (Plan, Do, Check, Act), Kaizen, Kanban to improve production processes; Performing deployment, update and maintenance of process control documentation, including Procedures, Work Instructions, Process Failure Mode and Effect Analysis, Device Master Record, and Master Validation Plan.; Utilizing Statistical tools, including Pareto Diagrams, to measure KPI's and track their progress, and DOE (Design of Experiments) and ANOVA (Analysis of Variance) to improve them.; Performing manufacturing site evaluation for Capital Expenditure projects; Composite structural design for manufacturing using CAD (Computer Assisted Design) and FEA (Finite Element Analysis). Position requires 25% domestic and international travel. Salary: $141,960 / year.
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.