Manufacturing Engineer Intern

Kimball Electronics•Indianapolis, IN

About The Position

The Manufacturing Engineer Intern supports the development and implementation of new manufacturing processes, maintains existing processes, and drives improvements to meet quality, cost, and delivery goals. The role develops assembly processes, creates manufacturing work instructions and testing procedures to support regulatory requirements, and conducts product and process analysis to improve quality, reduce costs, and increase efficiency. The intern is expected to maintain timely, consistent, and accurate work records and train manufacturing associates. A strong focus on quality is essential. In the first three months, the intern will learn KEIND quality system requirements and Kimball Electronics philosophies and culture; build relationships with team members; document and develop process flows for a critical medical device product launch; design equipment or tooling; write technical documentation; assist with production-system commissioning and validation; maintain customer-specific documentation supporting FDA requirements; work with project managers on project plans; participate in risk assessments; and take part in Lean manufacturing training and projects.

Requirements

  • Enrolled in a four-year degree program in Engineering or Engineering Technology, such as Mechanical, Electrical, or Biomedical Engineering.
  • Self-motivated, with excellent communication skills and a positive attitude.
  • Ability to manage time and projects effectively and set and meet aggressive schedules.
  • Ability to maintain timely, consistent, and accurate work records.
  • Ability to analyze data using statistical methods.
  • Ability to compose professional documentation, including protocols and work instructions.
  • Ability to analyze and solve problems using root cause analysis tools.
  • Quality-minded approach focused on data-driven decisions.
  • Ability to understand business, legal, and regulatory requirements.
  • Ability to learn regulatory requirements, including FDA 21 CFR 820 and GMP medical device regulations.

Nice To Haves

  • Three months to three years of relevant intern work experience, with knowledge of a variety of production methods and materials.
  • Validation experience, including process and equipment qualification (IQ, OQ, PQ), test methods, and R&R.
  • Process development or characterization experience.

Responsibilities

  • Develop and implement new manufacturing processes and support existing processes.
  • Verify processes and drive improvements related to quality, cost, and delivery.
  • Develop assembly processes and create manufacturing work instructions and testing procedures.
  • Analyze products and processes to support quality improvements, cost reductions, and increased efficiency.
  • Maintain timely, consistent, and accurate records of work.
  • Train manufacturing associates.
  • Learn KEIND quality system requirements and Kimball Electronics philosophies and culture.
  • Document and develop process flows for the launch of a critical medical device product.
  • Design equipment or tooling to support a manufacturing process.
  • Write technical documentation.
  • Assist with validation efforts for commissioning production systems.
  • Maintain customer-specific system documentation in support of FDA regulatory requirements.
  • Work with project managers to execute project plans.
  • Participate in risk assessment activities, including PFMEA and DFMEA.
  • Participate in Lean manufacturing training and projects.
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