We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI. The Associate Manufacturing Engineer is a motivated, self-starter who will assist and own parts of the creation, implementation, maintenance and continuous improvement of manufacturing processes, systems, and documentation necessary, to support production of medical devices working together with the Engineering department 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 with an eagerness to learn. Excellent interpersonal skills while working with high customer visibility are also critical to success in this opportunity.

The Associate Manufacturing Engineer will work with Operations, Supply Chain and Quality Assurance while carrying out duties for this position. The Associate 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 supporting production line qualification activities, process qualifications, monitoring and reduction of 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 processes and equipment adhere to Quality Management System Guidelines and SOPs, Federal Regulations, and International Standards while following good documentation practices.
• Supports production line qualification activities, process qualifications, calibration, monitoring and reduction scrap, and efficiency evaluations.
• Work hands-on to develop system level design strategies and supports 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.
• Works with operations, engineering and quality to ensure maximization of line utilization, material flow, and efficiencies while reducing scrap.
• Rapidly and correctly determine root cause(s) of process and equipment 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

• Bachelor of Science Degree in Mechanical, Manufacturing, or Electrical Engineering with 1-3 years of relevant experience post degree is required.
• Medical device manufacturing experience is not required, but would be helpful in this role.
• Must be able to generate, follow and explain detailed processes and operating procedures (i.e. assembly instructions, inspection procedures, maintenance schedules and guidelines, and proposals). 
• Must be able to analyze and recommend solutions to correct complex product and/or process issues using independent judgment. 
• 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 excellent analytical skills and the ability to provide mathematical solutions based 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, but not required
• Experience with form, fill, seal machines is a plus.
• Basic computer skills required (word processing, spreadsheets, database)
• Frequent pushing, pulling, and carrying up to 45 pounds may be required along with sitting, standing, walking, bending at the waist and knees are required at various times[AR1] 
• Proof of degree and transcripts and references must be provided upon request.
• Employment at Keystone is contingent on background check and drug screen prior to start date.

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