Biomedical Design Manager
Are you ready to join one of the fastest growing medical manufacturing companies? Do you have a degree in Biomedical Engineering, Electrical, Mechanical, Materials,ect. Manufacturing is the heart of Katecho. We are an internationally recognized, full service original equipment manufacturer (OEM) specializing in medical and cosmetic devices. From small volume, hand-assembled products to highly automated computer-controlled fabrication, our clients are assured quality, consistency and on-time delivery.
This Department manager position provides leadership in the areas of designing product from initial planning stages to product release, and insure proper documentation is provided in accordance with quality standards (AAMI specifications, ISO-13485 FDA design controls or similar regulatory, etc.) Prepares and presents design documentation for new and equivalent products.
Provides leadership and guidance for non-routine problems requiring substantial judgment in the independent evaluation, selection, and adaptation of standard engineering techniques, procedures and criteria. Manages a team of Product Design Engineers. Interacts with customers and vendors on product-specific issues. Manages all aspects of product structure, including all corresponding Engineering documentation, data entry, labeling, packaging, etc. Material selection. Provides basic quoting and quoting support. Designs, develops, and improves new or existing products.
Interacts with customers and vendors on product-specific issues that relate to design, production, lead times, delivery, etc.
Manages all aspects of product structure, including all corresponding Engineering documentation, data entry, labeling, packaging, etc.
Material selection.
Provides basic quoting and quoting support.
Designs, develops, and improves new or existing products and directs the building and testing of prototypes to completion.
Manage and assign engineering projects in accordance with customer specifications and within scheduling and budget limitations.
Coordinate with internal departments and functions to ensure a producible design.
Work on continuous improvement in the areas of product design and manufacturing methods.
Ensure necessary engineering documentation with correct specifications is provided in a timely manner for all components, assemblies, finished products and R & D projects.
Ensure engineering review and approve is completed for purchase orders and that specifications and descriptions listed are correct.
Ensure engineering review of customer orders is completed prior to processing, and correct documentation is provided.
Ensure documentation meets all regulatory and quality specifications and requirements.
Provide technical guidance and ensure sound engineering procedures are followed.
Work on new designs and improvements to existing designs in a continuing effort to meet our customers’ needs and remain competitive in the industry.
Bachelor’s degree in Biomedical, Electrical, or Mechanical, Materials etc.
Prior experience bringing product from conception to design to release required.
Knowledge of design processes, preferably in medical device industry. Cross-discipline engineering experience.
Experience in a manufacturing environment.
Materials knowledge.
Financial knowledge and skills including analysis and understanding of cost computations cost benefit and buy analysis.
Knowledge of process development steps required to take a process or project from concept through implementation.
Able to solve practical problems with a variety of variables in situations where only limited standardization exists.
Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
SPC (Statistical Process Control)_
Great interpersonal skill with excellent communication
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