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.

Description

Position Overview

The Production Supervisor is responsible for directing the activities of production employees engaged in manufacturing medical devices. The Production Supervisor is also responsible for training and supervising employees, ensuring compliance with the safety and quality standards established by the company and other supervisory activities including time and attendance management. 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.

Essential Job Functions

• Strong Lean manufacturing and 5S experience.
• Experienced in NCR initiation, investigation, and closure.
• Establishes and maintains department standards for safety, productivity, reliability, and accuracy.
• Ensure 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.
• 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.
• Assist in failure analysis, troubleshooting, rework/repair of non-conforming manufactured product to determine root cause.
• Estimate materials, tools and supply requirements and provide coordination of fulfillment.
• Troubleshoot work problems with employees; convey a sense of urgency and drive issues to closure.
• Participate in developing new procedures and processes to improve manufacturing or introduce new products.
• Create, route, collaborate and approve document change orders that affect production documentation.
• Support experimental builds using documented guidelines provided by engineers.
• Manages staffing through coaching and development, employment decisions and resolving employee issues through problem resolution.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, rewarding positive behavior, and applying disciplinary action as appropriate.
• Monitors daily work metrics and provides direction and guidance to skilled nonexempt staff to achieve unit or project goals.
• Communicates to line personnel daily while maintaining a constant line presence.
• Communicates with other departments and functions as needed in support of meeting operational objectives.
• Inspects for proper sanitation of equipment and facilities; takes corrective action to resolve deficiencies.
• Maintains a working knowledge of all operating systems pertaining to the work area.
• Assist in time studies to quantify processing times and identify areas for process improvements.
• Adapt to frequent changes in the work environment; manage multiple tasks and competing demands.

Requirements

• Bachelor's degree or equivalent experience.
• Minimum 5 years of experience as a Manufacturing Supervisor.
• Experience working with manufacturing/ERP systems (QAD and Oracle preferred).
• Experience with Microsoft Office or similar computer software.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations, and good manufacturing practices (GMP).
• Experience working with a clean room environment, and application of environmental procedures
• Excellent written and oral communication skills
• Strong interpersonal and communication skills with the ability to clearly provide work direction, communicate with support staff and present recommendations and ideas and to build consensus.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer #LI-SP1