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Engineer - Plastic Molding

Job Code - EC0832

Title: Molding Engineer Medical interconnect and plastic - San Diego, CA
A global supplier of custom interconnect and electric packaging solutions for the medical industry. With technologies that include stamping, molding, plating and assembly of precision parts. Is seeking an experienced Molding Engineer in our San Diego facility.
This position is part of a centralized Corporate Product Development Team that is focused on Mechatronic Product Development primarily for the Medical Industry He / She will support major molding projects. As a key member of Medical Business Unit and he or she will be expected to: Lead the execution of molding process development, product validations, documentation, process capability and process qualification; Contribute during all phases of product development; Introduce new components and processes, test methods and tooling to operations; Interface with all key stakeholders to define and satisfy customer requirements; And develop and manage discrete tasks as well as complex projects to a detailed schedule. The successful candidate will be comfortable working on Product Development and Engineering teams as an overall rounded engineer with responsibilities in all phases including design engineering, project management and test engineering. This candidate should also enjoy the development process through a combination of mechanical, electrical and electronic technologies that depend on his/her high degree of development capabilities.
This position requires design experience in a highly regulated environment such as medical, automotive or military along with experience in electromechanical assemblies. The applications include patient monitoring, surgical and imaging as well as other electronic connectivity requirements in the medical field. The emphasis of this position will be on the development of new products both driven by internal specifications as well as external customer requirements including, design, development, testing and project management in a high-paced, results driven environment. This person would have experience injection molding, FEA and DOE/test methodologies with knowledge of RoHS and ISO-13485 requirements.
Work with new product teams and advise on robust design and design for manufacturability of new products. Lead the mold tool and process design reviews during all phases of product development. Provide estimated tooling and process costs.
Manage the transfer of new components and processes from development into production by performing process development, capability studies, validations, and specification generation. Oversee the scheduling of "first shots", mechanical debugs, process development and FAI.
Translate customer (internal and external) expectations and develop project plans. Maintain projects with regularly scheduled team meetings and management updates. Responsible for reconciling scheduling conflicts and maintaining delivery dates.
Drive the use of scientific molding to develop standard processes. Leverage typical statistical techniques and methods such as Design of Experiments (DOE) to develop robust processes and translate information to standard process specifications.
Provide training to Manufacturing Engineering, Technicians and Set-Up Operators on new and revised processes.
Participate actively in the design and procurement of new equipment, tooling and processes. Provide insight and recommendations during specification, quoting, procurement and design reviews.
Collaborate with Quality and Operations to ensure adherence to Surgical and Cables' Quality systems, such as CAPA, failure mode investigations, FDA and ISO standards. Supports the maintenance of standard operating procedures (SOP) relevant to molding.
Maintain compliance to the Surgical and Cables' Quality Management System (QMS) requirements. Ensure all documentation is prepared and completed to meet QMS and customer requirements (i.e. NPI requests, work instructions, engineering technical reports, validation protocols and reports, FMEA's, equipment specifications and product specifications/prints).
Provide technical support to Operations to resolve issues (equipment, process, and documentation) and assist the molding team with problem resolution.
Assess and track yield, labor and material performance and identify variances and defects for newly introduced components and processes to measure results against original estimates.

Minimum of 5 years experience in the Design and Development of custom products in a regulated environment (Medical Preferred)
Strong understand of 3D CAD systems (SolidWorks preferred)
Strong problem solving and analysis capabilities including FEA, CFD and tolerancing
Experience with Microsoft Office suite: Word, Excel, PowerPoint, Project
Experience in overmolding of cables assemblies or insert molding preferred.
Bachelor's degree in Plastics or related engineering discipline or equivalent.
Experience in LSR molding
Must have an extensive knowledge of plastics engineering principles, theories, concepts, practices and techniques typically associated with scientific molding. Working knowledge of molding machines and ancillary equipment.
Proficient in quality management systems, lean principles, quality engineering practices and principles. Familiar with ISO standards and certification process: ISO 9001:2008 and ISO 13485:2003.
Working knowledge of six sigma and lean manufacturing tools. Six Sigma Black Belt is a plus.
Strong analytical and problem solving capabilities.

Qualified resumes to;