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. Designing, implanting, and reviewing the procedures and equipment involved in the manufacturing process. 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 internal departments and functions to ensure a producible design.
   2. Work on continuous improvement in the areas of product design and manufacturing methods.
   3. Develop guidelines for the development of manufacturing inspection/test procedures and equipment
   4. Responds to Production needs by proposing & initiating changes to products, labeling, packaging, fixtures, etc.
   5. Provide Production assistance with print interpretation & provide direction in Production Line Down calls; Deviation & NCR cause & solutions.
   6. Evaluate quality control processes and make recommendations for improvements.
   7. Analyze production processes, schedules, methods, and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
   8. Ensure that the company's manufacturing processes are in compliance with all government laws and regulations.
   9. Review and calculate labor, material and other production costs along with reviewing schedules and future production requirements to assist management in decision making.
   10. Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.
   11. Coordinate equipment maintenance and repair services and make sure that manufacturer's procedures and instructions are followed in order to keep production equipment operational.
2. Under the direction of the Manager 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.

Experience and Skills:

QUALIFICATIONS

1. Bachelor’s degree in Engineering or related field; or equivalent experience
2. 1-3 yrs’ experience
3. Ability to lead and influence others by example in the areas of attitude, work quality, work ethic, dependability, and company loyalty.
4. Ability to understand finished design drawings produced by the design concept team including layouts and tolerance valuations for detail product drawings.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. The employee must be able to communicate with speech and hearing. Specific vision abilities required by this job include close and distance vision.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire. Some travel may be required.

Benefits

• PTO awarded immediately.
• 7 paid holidays, including New Year, Memorial Day, 4th of July, Labor Day, Thursday & Friday for Thanksgiving, Christmas Day.
• Full benefits, including Medical, Dental, Vision, STD, LTD & Life options available.
• 401k plan w/ 25% unlimited match, vested in 3 years.