MGR OF MANUFACTURING ENGINEERING - Santa Barbara, California
MEDICAL DEVICE MOLDED PRODUCTS
Job Summary:
Lead product/processing development for medical device products- molding and extrusion. Also, injection machine processing, tooling concept direction and plant support during project launch and troubleshooting. Supervise Data Admin, Project Mgr, Cost Estimator, Tooling Eng, Product Development Mgr & Packaging Engineer.
Job Duties and Responsibilities:
Manage development of tooling and processing solutions to meet the stringent demands of waste-less liquid injection molding. (LIM).
Coordinate/manage tool designers, programmers, and engineers to support LIM tooling.
Coordinate/standardize system and procedural implementation for Engineering Team.
Coordinate/manage production support through documented process set-ups, monitoring, and adjustments. Oversee Program Management and Process improvement & optimization.
Help troubleshoot equipment, tooling, and materials for samples and production.
Supports new product quote activities through process description, part costing, packaging, process FMEA and control plans.
Participates in the financial justification, selection, purchase, installation, and start-up of new equipment projects.
Communicate with customers and suppliers as required.
Focuses on reducing costs of existing product through efficiency, scrap reduction, etc.
Performs necessary functions to adhere to FDA & ISO13485 standards.
Qualifications:
B.S. Mechanical Engineering / Chemical Engineering or related technical degree.
5-10 years hands-on liquid rubber/silicone/plastic injection molding processing and tooling experience. Extruded medical products processing desired.
Strong Product Engineering, Tooling, Process experience for molded medical products.
Experienced with FDA and Cleanroom guidelines.
Hands on Engineering supervision and/or team leadership experience.
Delegating, leading coaching, mentoring, supporting & developing team members.
Knowledgeable in Lean/Kaizen Systems and Six Sigma methodology.
CAD and programming knowledge.
Strong computer skills: Word, Excel & MS Project.
(Must have all requirements bolded or underlined.)
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