Production Manager InfraReDx
THIS JOB HAS EXPIRED The Production Manager will supervise catheter manufacturing production lines and coordinate the scheduling of people, materials, and equipment to attain daily production goals. Ensure the quality of the products as a top priority. Interact with engineering, quality, and materials functions to coordinate and resolve production related issues. Relentlessly drive continuous improvement through LEAN manufacturing concepts and Six Sigma tools. Perform all personnel related functions related to production assembly staff including hiring, training, and performance evaluations.
Participates in the overall planning, supervision and direction of activities related to the manufacturing operations of disposable single use catheters and sterile accessories.
Directs the work of production operators and provides technical guidance on operational problems.
Responsible for the documentation and qualification (IQ, OQ, PQ) of all manufacturing, inspection, and test equipment.
Lead initiatives to improve operations; increase yield, decrease scrap, reduce WIP, streamline work processes, all while maintaining product quality.
Lead product transfers from Product Development to Manufacturing.
Implementation of cost reduction program.
Ensure integrity and timeliness of input of catheter production data in MAX,
Report on performance metrics such as daily production, inventories, shop floor control, defects, and scrap as well as provide solutions for improvement based on data delivered.
Participate in corrective action plans and engage in the continuous improvement process.
Coach staff and develop resources for top performance.
Develops drawings and specifications of new equipment and modifications to existing equipment.
Plans and executes Validation programs for manufacturing processes, equipment and controls. Develops, reviews, and manages validation protocols and summary reports.
Prepares and maintains documentation requirements to support manufacturing processes.
Works in conjunction with Director of Materials to ensure appropriate levels of materials inventory while balancing cost of holding that inventory.
Provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met to meet strategic goals and objectives of the company.
Design, develop, and validate improved and/or automated tooling and fixturing.
Monitor performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
Support daily production activities by troubleshooting process and equipment issues.
Work with cross-functional groups including Quality Engineering to analyze and disposition non-conforming products.
7 years experience (at least 3 within fast-paced manufacturing environment and 2 years supervisory experience.)
Bachelor?s degree required (technical or business), or demonstrated equivalent experience.
Medical device or chemical processing experience preferred.
Experience in the areas of process automation, material flow, lean manufacturing, ergonomics, manufacturing cost reduction, quality improvement programs, plus experience working within a team environment.
Extensive background in design improvement programs, validating of semi-automated equipment, significant experience in statistical analysis and process control, Design of Experiments, and risk management.
Should have exposure to medical device manufacturing processes such as RF Induction processing, plastic injection molding, plastic extrusions, knowledge of welding (plasma/laser/resistance), and soldering knowledge.
Disposable medical device and/or medical capital equipment manufacturing experience is a plus.
Training/Certification in Six Sigma problem solving skills highly desired.
Excellent communication and interpersonal skills required (written and verbal).
LEAN Manufacturing experience preferred.
Must be proficient in MS Word, Excel, PowerPoint and Project, as well as CAD literate (SolidWorks preferred).
Must be able to manage and execute projects through various stages of development with minimal supervision.
||34 Third Avenue |
Burlington, MA 01803
THIS JOB HAS EXPIRED