Manufacturing Engineer

6 days ago

Augusta, United States Apex Systems Full time

Apex Systems is seeking a Manufacturing Engineer to support a top healthcare services company onsite in Augusta, GA. The position will begin as a 6-month contract with strong potential for extension and will have a Monday-Friday first shift schedule. This role will be responsible for developing manufacturing processes, qualifying changes to products, running validations, and associated tools.


Responsibilities:

  • Reviews new design changes for manufacturability.
  • Designs process improvements to reduce product cost, process cycle time and improved product quality.
  • Create documentation to support new and improved manufacturing processes
  • Write and perform process validations
  • Make recommendations for equipment purchases based upon manufacturing needs
  • Perform IQ/OQ/PQ as required on equipment
  • Disposition NCRs and CAPAs as assigned
  • Perform experiments including DOEs to characterize and improve processes Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis
  • Coordinate with suppliers and external resources needed in developing and implementing new processes
  • Work closely with R&D and Manufacturing to capture and interpret design intent in order to refine and improve processes
  • Facilitate excellent communications between all team members
  • Responsible for communicating business related issues or opportunities to next management level
  • For employees with supervisory responsibilities, ensure that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Also ensure compliance with Quality Procedures, Laws and Regulations of the applicable markets Performs other duties assigned as needed

Qualifications:

  • Bachelor's degree required - some majors that would fit the role in order of top priority are Mechanical Engineering, Electrical Engineering, or Industrial Engineering
  • 3+ years related work experience, preferably in a medical device manufacturing environment preferred
  • Experience performing IQ/OQ/PQ in an FDA regulated environment
  • Excellent hands-on communication and interpersonal skills Experienced in MS Word, Excel, and Project Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process. Failure Mode and Effects Analysis (FMEA)
  • Strong Lean Manufacturing background preferred.
  • Must be able to multi-task and operate in a fast-paced environment with minimal training and supervision.
  • Strong written, verbal, and interpersonal skills.
  • Ability to effectively interact with all levels of employees and management, both in the Manufacturing group and cross-functionally
  • Excellent computer skills including advanced working knowledge of Microsoft Office (Word, Excel, Outlook, etc.)
  • Understanding of regulations related to FDA, GMP/MDD, and ISO preferred

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