Manufacturing Engineer II

Overview

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI.  The Manufacturing Engineer is a motivated, self-starter who will lead and assist in the creation, implementation, maintenance and continuous improvement of manufacturing equipment, processes, systems, and documentation necessary to support production of medical devices for Keystone Manufacturing.

The successful candidate must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively.  This candidate must have great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress.  Excellent interpersonal skills while working with high customer visibility are also critical to success in this opportunity.

The Manufacturing Engineer will work with Product Development, Operations, Supply Chain and Quality Assurance while carrying out duties for this position.   The Manufacturing Engineer serves as the voice of engineering throughout the product’s life cycle.  The Manufacturing Engineer’s primary focus will include sustaining and continuous improvements in support of ongoing production, as well as troubleshooting and debugging of production lines and equipment. This position is also responsible for production line qualification activities, process qualifications, monitoring and reduction scrap, and efficiency evaluations.  Other tasks may include supporting preventative maintenance activities, calibrations, and onboarding of new product lines. This position requires the application of a broad knowledge of principles, practices and procedures within the manufacturing and maintenance specialization in the completion of difficult assignments.
   
Responsibilities and Activities 
  

• Ensures production equipment and processes adhere to Quality Management System Guidelines and SOPs, Federal Regulations, and International Standards while following good documentation practices.
• Work hands-on to develop system level design strategies, make recommendations to management and coordinate implementation of equipment and systems focused on process improvements and efficiency gains. 
• Support the design, development, testing & refinement of systems, and sub-systems used in the manufacture of products. 
• Report opportunities for improvement clearly and concisely, recognizing and highlighting specific deviations as well as provide status reports and progress reviews.
• Owns manufacturing processes and works with operations to ensure maximization of line utilization, material flow, and efficiencies while reducing scrap.
• Supports equipment preventative maintenance and calibrations to ensure equipment utilized in the production of goods operates and peak efficiency with minimal down time.
• Rapidly and correctly determine root cause(s) of equipment and process faults and product non-conformances and formulates recommendations and implements fixes and corrections. 
• Projects and assignments are general and open ended in nature and requires inventiveness and creativity in finding solutions. 
• Listen and work with others to contribute new ideas. 
• Must demonstrate a commitment to quality and customer satisfaction for both internal and external customers, and maintain a high standard of ethics.
• Perform other duties as assigned

Minimum Requirements and Qualifications

• Minimum of a Bachelor of Science Degree in Mechanical, Manufacturing, or Electrical Engineering with 10 years of relevant experience is required.  15+ years of experience is preferred.
• Medical device manufacturing experience is preferred.
• Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. assembly instructions, inspection procedures, maintenance schedules and guidelines, and proposals). 
• Must be able to analyze and correct complex product and/or process issues using independent judgment. 
• Must be able to routinely make decisions that immediately impact operations. 
• Must be able to plan, organize, document and implement multiple concurrent tasks.
• Must have the ability to work with and assemble small objects and component parts. 
• Must have the ability to operate hand tools, inspection equipment, and common office equipment. 
• Must have the ability to operate in a fast-paced environment, sometimes requiring extended work hours, including evenings, weekends and holidays as necessary, to ensure minimal interruption to production.
• Must be able to work in both an office environment and manufacturing work cells and cleanroom environments
• Must be able to perform sedentary work with periods of active work such to support the organizations objectives
• Must have excellent analytical skills and the ability to provide mathematical solutions base on fundamental engineering principles.
• Must have excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers.
• Must have excellent documentation and organizational skills.
• Demonstrated mechanical and electrical problem-solving skills.
• Experience with single use disposable medical devices is a plus.
• Experience with form, fill, seal machines is a plus.
• Experience with electrical automation systems such as PLCs, servo drives, sensors, etc. is a plus.
• Experience with pneumatic automation systems and components is a plus.
• Experience with hydraulic automation systems and components is a plus.
• Proof of Degree and Transcripts must be provided upon request.
• References must be provided upon request.
• Basic computer skills (word processing, spreadsheets, database)
• Frequent pushing, pulling, and carrying up to 45 pounds may be required
• Sitting, standing, walking, bending at the waist/knees are required at various times

Schedule

Monday through Friday, sometimes requiring extended work hours, including evenings, weekends and holidays to ensure minimal interruption to production. The work environment for this position will be both an office environment and manufacturing work cells and cleanroom environments.

Benefits

• Excellent full-time benefits, including comprehensive medical coverage, dental and vision options
• Company paid life insurance, short term disability and long-term disability insurance
• Retirement savings plan with company match
• Paid time off and holidays, with the ability to schedule a day of volunteering once per quarter
• Flexible work environment, such as occasional work from home, is acceptable and encouraged as business needs and conditions allow
• Professional development opportunities