Manufacturing Engineer

The Manufacturing Engineer (ME) will lead sustaining efforts as well as value engineering objectives related to manufacturing process improvements.

  • Investigating and addressing product and process nonconformances using root cause analysis tools as appropriate.
  • Drives non-conformance corrective actions and documentation to completion.
  • Support manufacturing in resolving applicable product build issues.
  • Uses technical and business knowledge and expertise to support design and development projects by providing feedback on manufacturing processes and driving the transfer from development to manufacturing including any process qualifications or validations.
  • Assure product and process quality throughout the design, transfer to manufacturing, maintenance, scale-up, optimization, and qualification/validation of manufacturing processes or equipment.
  • Create and maintain manufacturing process documentation which accurately reflects all process requirements
  • Analyze and identify opportunities to improve products and processes, reduce cost, and manufacturing efficiency and layout.
  • Successfully lead multiple projects simultaneously to deliver all requirements in respect to timelines, scope, and cost.
  • Ensure that all objectives are successfully achieved as scheduled.
  • Ensure all change control requirements are satisfied and ensure compliance with appropriate regulations, policies, procedures, and standards.
  • Use Six Sigma and Lean principles appropriately to optimize processes, equipment layout, and improve efficiencies.
  • Prepare and present product and process reports by collecting, analyzing, and summarizing information and trends.
  • Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
  • Lead cross-functional teams in the planning and execution of assigned activities.
  • Manage all activities in a responsible, professional, and proactive manner.
  • Execute other duties as assigned by manager.
  • Bachelor’s Degree in – Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or other technical field.
  • Knowledge of regulatory systems – specifically FDA, ISO 13485, CE Mark, etc.
  • Excellent technical writing skills as well as verbal communications and interpersonal skills are required to interact with stakeholders, such as engineering, quality assurance, and auditors.
  • Strong project management, design, troubleshooting, leadership, and presentation skills.
  • Working knowledge of Six Sigma and Lean principles.
  • Working knowledge of DFMEA, PFMEA, and Risk Analysis Tools.
  • Working knowledge of DFA / DFM principles.
  • Knowledge of manufacturing operations, equipment, scheduling, and project management.
  • Experience dealing with complexity, manufacturing methods and procedure development/improvement, and manufacturing quality.
  • Strong computer skills including CAD software (SolidWorks experience preferred).
• 5 years of related experience preferred. • Six Sigma Green Belt or Black Belt certification preferred.
Manufacturing Engineer
Indianapolis, IN
Human Resources

HIFU company


10130 Perimeter Pkwy, Suite 250
      Charlotte, NC 28216

(888) 874-4384

Mon - Fri: 9:00 - 5:00

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