Job Description:

SUMMARY

Responsible for the design and development of medical device products. Partner with external customers to transfer product concepts and specifications into Katecho documentation. Build business relationships with our customers and potential customers with the objective of developing new product lines and expanding existing product lines. Handle product design projects from initial planning stages to product release.

PRIMARY DUTIES AND RESPONSIBILITIES

1. Designs, develops, and improves new or existing products. Responsible for the building and testing of prototypes to complete assigned engineering projects in accordance with customer specifications and within scheduling and budget limitations.
   1. Coordinates with customers as required.
   2. Coordinate with internal departments and functions to ensure a producible design.
   3. Work on continuous improvement in the areas of product design and manufacturing methods.
   4. Develop guidelines for the development of manufacturing inspection/test procedures and equipment
   5. Responds to Production needs by proposing & initiating changes to products, labeling, packaging, fixtures, etc.
   6. Provide Production assistance with print interpretation & provide direction in Production Line Down calls; Deviation & NCR cause & solutions.
2. Under the direction of the Director of Engineering, will ensure necessary engineering documentation with correct specifications is provided in a timely manner for all components, assemblies, finished products and design projects.
   1. Creates and organizes complete product structures, including prints, item cards, bills of material, ECO’s, work-order verification, once a design concept or final design has been completed.
   2. Generates all necessary documentation for product changes (internal or customer- requested), including ECO’s, Deviations, prints, etc. Verifies work-in-process affected by changes.
   3. Prepares assembly, and detail drawings for released or improved products, labels and packaging.
   4. Enters changes and maintains necessary data into ERP system.
3. Builds relationships with Katecho’s customers not only profitable for the company in terms of the product sold, but also rewarding to the customer in terms of the quality of the product purchased. Performs research and provides analysis related to potential new business opportunities for the company. Interfaces with our existing customers, and actively interfaces with potential customers with the objective of developing new product lines and expanding existing product lines.
   1. Work with the customers to resolve issues involved in the design of the product.
   2. Work on new designs and improvements to existing designs in a continuing effort to meet our customers’ needs and remain competitive in the industry.
4. Work with the Director of Engineering on directing the quoting for products of Katecho. Develops strategies for pricing products in continuing efforts to meet our customers’ needs and remain competitive in the industry.
   1. Ensure Katecho’s products are priced to accurately reflect raw material costs, labor costs, and overhead.
   2. Support product manufacturing by supplying alternate sourcing advice including vendor or component analysis, alternate manufacturing process deviations, and cost improvement design changes.

SECONDARY DUTIES AND RESPONSIBILITIES

1. Assists in the follow-up of prototype construction with outside vendors.
2. Secures quotations and expedites materials and delivery.
3. Other duties and functions may be assigned as required.

AUTHORITY

1. Approves art work upon arrival from the corresponding supplier.
2. Approves revision levels on work orders.
3. Request necessary supplies and resources to adequately complete the responsibilities listed above.
4. Must complete a Non-Compete Agreement and Patent Agreement.