We are looking for a talented individual to join our dynamic Keystone Manufacturing Team located in Kalamazoo, MI. This motivated, self-starter will work with Product Development, Operations, Production, Sourcing/Purchasing, and Quality Assurance while carrying out duties for this position.
The Advanced Manufacturing Engineer will work on supporting manufacturing related input for development programs and manufacturing related Design History File documentation while managing manufacturing transfers. The candidate must have a “can do” attitude, and possess creative problem-solving skills. 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 AME serves as the voice of operations as a new product is being transitioned to manufacturing and throughout the products life cycle.
Design for manufacturability and assembly are key aspects the AME will include while developing processes and systems and continuous improvements in support of ongoing production.
Responsible for production line qualification activities, process qualifications, calibration, monitoring and reduction scrap, and efficiency evaluations.
This position requires the application of a broad knowledge of principles, practices and procedures within the manufacturing specialization in the completion of difficult assignments.
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, systems, and processes.
Lead the design, development, testing and 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 material flow to ensure maximization of line utilization and efficiencies while reducing scrap.
Supports equipment and machine 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 using engineering fundamentals and a systematic approach to formulate recommendations and implement 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.
Requirements and Qualifications
Minimum BS in an Engineering discipline is required. No Engineering Technology Degrees will be considered.
Minimum of 3 to 5 years’ experience in Medical Device Manufacturing.
Must be able to work in both, office environment and manufacturing work cells and cleanroom environments.
Strong personal computer skills, including experience with MS office and MS Project.
Occasional offsite work, such as work from home, is acceptable and encouraged as business conditions allow.
Must be able to perform sedentary work with periods of active work such to support the organizations objectives.
Extended hours, including weekends and holidays may be required to support the organizations objectives.
Travel, less than 25%, to customers, suppliers, trade shows, and other needs as required.
Frequently pushing, pulling, and carrying up to 45 pounds may be required.
Sitting, standing, walking, bending at the waist/knees are required at various times.
Excellent communication and people skills is required.
Proof of degree and transcripts may be requested.
Candidate must pass background check and drug screen.
Must be authorized to work in the United States (this job does not offer sponsorship).
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.
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; educational assistance.