Job Summary

Plan, design, setup, modify, optimize, and monitor manufacturing processes and ancillary processes in order to produce high quality products in the most cost-effective manner.

Develops, evaluates, and improves manufacturing methods utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality standards. Analyzes and plans workforce utilization, space requirements, and workflow. Designs layout of equipment and manufacturing cells for maximum efficiency utilizing lean manufacturing tools. Estimates production time, staffing requirements and related costs to provide information for management decisions. Confers with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes. Ensures that manufacturing processes meet regulatory compliance requirements.

For more information on our company and products, please visit www.etac.us.com & www.kimobility.com

Essential Functions

Job Responsibilities

Implement manufacturing processes for the introduction of new products, or for the improvement of existing products, that result in the highest quality product at the lowest total cost.
Apply lean principles and techniques to manufacturing and ancillary processes.
Be knowledgeable about design for manufacturability to clearly analyze and communicate manufacturability costs and quality requirements.
Work with design engineers to ensure all product requirements are taken from initial product conception to the finished device.
Conceptualize, purchase, and qualify new equipment, tools, and fixtures for manufacturing.
Design, fabricate, and qualify custom tools; includes working with local shops on sourcing and design.
Oversee junior level personnel such as Jr Manufacturing Engineers, lean support personnel, or CNC programmers.
Develop preventive maintenance plans for manufacturing equipment.
Assist in the research, testing, and implementation of materials, processes, and/or suppliers when required.
Evaluate existing manufacturing processes and procedures to develop improvements in efficiency, quality, and cost reduction.
Develop and lead Kaizen events or other projects to optimize manufacturing processes.
Ensure and follow safety requirements and standards.
Adhere to Company’s Quality Management System requirements.
Maintain a safe, neat, and orderly work environment.
Perform all duties in a manner that follows, demonstrates, and promotes Company’s values.
Report to work as scheduled, on time, and able to work entire work schedule.
Perform additional duties as assigned.

Knowledge, Skills, and Ability

Critical thinking skills with the ability to analyze data and draw accurate conclusions.
Ability to obtain or have knowledge of regulatory requirements in the medical device industry.
Knowledge of component manufacturing processes including metal forming, machining, and injection molding.
Knowledge of Lean Manufacturing and/or Lean Enterprise.
Ability to effectively present information and respond to questions in meetings and design reviews.
Detail oriented.
Possess a continuous improvement mindset.
Possess effective written and oral communication skills.
Ability to work effectively both independently and within a team environment.
Ability to be highly adaptable and responsive to changing business needs.
Intermediate level skills using computer applications (Word, Excel, enterprise software).
Knowledge of CAD software.
Familiarity with pneumatic and hydraulic controls, PLC, and machine control systems.
Skill and ability in GTAW welding with aluminum.
Skill and ability with Geometric Dimensioning and Tolerancing, GD&T.
Intermediate math proficiency.
Ability to obtain a passport if needed for international travel.
Ability to observe and identify details.
Ability to work extended hours as scheduled, including weekends.

Physical Demands

Frequent sitting, wrist manipulation, walking, and standing.
Frequent sedentary work with lifting up to 10 pounds.
Occasional medium work with lifting up to 40 pounds.
Manual dexterity to type and operate office equipment occasionally.
Manual dexterity to use hand tools for assembly and measuring.
Must be able to complete all physical requirements to perform essential functions.

Qualifications

Education

Degree in an engineering discipline (Mechanical Engineering, Manufacturing/Industrial, or Quality Engineering preferred) or 1-3 years’ experience in a Manufacturing Engineer or similar engineering position.

Experience

Required:
1. 1-3 years of experience in a manufacturing environment.
2. Experience in Lean Manufacturing and/or Lean Enterprise.
3. Experience reading and interpreting engineering drawings.
4. Manufacturing, mechanical, mechanical inspection, or machining experience.
5. Experience using mechanical or automated inspection tools.
6. Intermediate level experience with Microsoft Office programs (Word, Excel) and other enterprise software.
Preferred:
1. Experience with ISO 13485 and 14971.
2. 2-3 years’ experience in an FDA regulated environment, preferably medical device.
3. 2-3 years’ experience working in a manufacturing engineer position in a manufacturing environment.

Working Environment

Standard working conditions include an office environment and manufacturing environment.
Position requires domestic and international travel up to 5%.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodations.

Ki Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.