Sr. Production Supervisor
Description
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
This role is responsible for leading supervisors and the manufacturing personnel to produce high quality products according to quality, safety and cost standards defined by the company. The Production Supervisor is required to supervise all production activities performed by employees, maintaining a high degree of visibility and access to employees throughout the shift. This position is the point of contact for other departments for production related issues.
Essential Job Functions
- Ensures compliance to quality systems (FDA, GMP, QSR, ISO), product specifications, process instructions, safety requirements and company policies. Includes the diligent management of non-conformances to ensure appropriate corrective and preventive actions.
- Estimates materials, tools and supply requirements and provides coordination of fulfillment.
- Participates in developing new procedures and processes to improve manufacturing or introduce new products.
- Creates, routes, collaborates and approves document change orders that affect production documentation.
- Supports experimental builds using documented guidelines provided by engineers.
- Leads production team in achieving production goals around Safety, Quality, Service and Cost.
- Identifies team members’ training requirements and ensures that individuals are appropriately trained before assignment to a work detail.
- Hires, trains, develops and evaluates production personnel to ensure the appropriate resources and talent are in place.
- Evaluates team member’s performance as well as development opportunities on a regular basis in a written performance review.
- Retains responsibility for product from initial assembly to final distribution. Schedules and organizes assigned manufacturing lines to achieve 100% product availability and maintain targeted levels of inventories.
- Monitors daily work metrics and provides direction and guidance to skilled nonexempt staff to achieve unit or project goals and troubleshoot work problems with employees; convey a sense of urgency and drive issues to closure.
- Monitors inventory levels and coordinates daily activities with Planning.
- Adapts to frequent changes in the work environment; manage multiple tasks and competing demands.
- Contributes to the development of improved manufacturing methods by sharing ideas with engineers and management through both verbal and written communication.
- Creates tools to track, analyze and report key indicator data and metrics for areas of responsibility.
- Manages and leads production projects from start to completion, ensuring projects are completed in a timely manner.
- Ensures all production reports are up to date and accurate. Utilizing the data for continuous improvement and recommendations.
- Ensures overall headcount is aligned to the latest build forecast to support business goals.
- Other duties as assigned.
Requirements
· Bachelor's degree in Engineering or equivalent degree.
· 3 to 5 years of experience in manufacturing environment in medical industry
· At least 3 years of experience as a Production Supervisor.
· Experience working with manufacturing/ERP systems (QAD or Oracle is a plus).
· Proficient in Microsoft Office
· Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations, and good manufacturing practices (GMP).
· Working knowledge of Lean Manufacturing Principles, Six Sigma and 5S.
· Excellent written and oral communication skills.
· Experience working with a clean room environment, and application of environmental procedures.
· Other duties and projects as assigned.
Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.