Job Title: Production Manager - LipoSonix
Location: Bothell, WA
Zip Code: 98011

Description:

Overview :

This position is responsible for overall management of LipoSonix production including: performance to the production plan, quality, personnel, labor cost, equipment, and facilities. It assists planning, and directs the layout of equipment, workflow, assembly methods, and utilization. It creates and maintains all internal production specific business operating processes.

Primary Responsibilities :
* Develop, coach, and retain a high performance production staff. Provide drive, vision, leadership, guidance, and support to all direct reports.
* Manages production team. Including: hiring, retention, goals and objectives, performance reviews, and development plans.
* Establishes and manages all production operational documentation.
* Develops and manages a world class production operation through lean implementation.
* Develops the production layout including equipment, workflow, methods, and utilization.
* Ensures a safe working environment.
* Ensures all production personnel are trained to current released instructions and procedures.
* Ensures all production equipment is within calibration and preventative maintenance cycle.
* Ensures compliance to the LipoSonix Quality System.
* Develops the production build plan. Works with planning to ensure build plan supports forecast.
* Develops staffing and training plans based on build plan.
* Leads production capacity planning activities.
* Manages production resources to meet the production build plan.
* Develops, tracks, and analyzes metrics to measure production performance and drive continuous improvement (quality, build plan, cost, utilization, etc.).
* Responsible for meeting established production objectives.
* Performs data analysis and trending on manufacturing processes.
* Utilizes troubleshooting, root-cause analysis, and improvement activities to increase quality and yields, and reduce cost.

Responsibilities :
* Demonstrated ability to lead a diverse group of temporary and regular employees to meet an aggressive and flexible forecast.
* Ability to evaluate, train, coach, and motivate direct reports.
* Demonstrated ability to drive production process improvement through equipment, methods, and design.
* Experience utilizing and implementing lean manufacturing concepts.
* Experience at metric development, analysis, and reporting.
* Experience in setting up production lines and processes.
* Experience in process verification and validation.
* Experience working within an ISO 13485:2003 or like quality system.

Qualifications :

* Bachelor's degree in engineering or related field and 7 years background in production support or leadership role.
* An understanding of the FDA Quality System Regulation.
* Experience in a medical device capital equipment manufacturing environment.
* Background in diagnostic or therapeutic ultrasound.
* Strong project management and financial feasibility skills.
* Excellent verbal and written skills. Hands on and team oriented.
* Self starter with good problem solving skills.
* Ability to work with minimal direction.
* A self-motivated and results-oriented individual.
* Possess the ability to work with all levels of leadership.
* Strong PC skills required - Word, Excel, etc.
* Strong analytical skills.
* Able to lift and carry a minimum of 25 lbs. with or without accommodations.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be constructed as an exhaustive list of all responsibilities, duties, and skills for this job.

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