Job Title: Manufacturing Engineer - Dallas, Texas

Medical Device

Job Description

We are seeking a highly skilled Manufacturing Engineer to oversee the design of production machinery and recommend solutions to production problems related to materials, processes, and tooling. The ideal candidate will conduct advanced engineering studies, champion LEAN and other improvement initiatives, and collaborate with product development teams to ensure superior manufacturability. This role requires translating design requirements into process and equipment requirements, developing and documenting equipment qualifications and process validations, and supporting test method and inspection method development.

Responsibilities

• Oversee the design of production machinery.
• Recommend solutions to production problems related to materials, processes, and tooling.
• Conduct advanced engineering studies to achieve significant output improvements.
• Champion LEAN and other improvement initiatives.
• Collaborate with product development teams to ensure superior manufacturability.
• Translate design requirements into process and equipment requirements.
• Develop, execute, and document equipment qualifications and process validations, including IQ/OQ/PQ plans and reports.
• Support test method and inspection method development and validation during design verifications, process validation, and commercial manufacturing.
• Develop, implement, and support production documentation, including manufacturing procedures, routers, and bill of materials (BOM).
• Provide engineering support to customers, equipment suppliers, and contract manufacturers.
• Lead and train less experienced engineers and technicians.
• Work closely with executives to implement manufacturing strategy and metrics.
• Design tools and machines used to manufacture products.
• Review production program equipment, hardware, and tooling, making recommendations for repairs or replacement.
• Oversee the development of new processes, methods, and production controls.
• Install new equipment and ensure it operates correctly.
• Train others to operate machinery.
• Prepare operations manuals for new or existing equipment.
• Utilize tools such as value stream mapping, overall equipment effectiveness, and 5S to improve quality, labor efficiency, throughput, and cycle time.
• Maintain knowledge of new and developing manufacturing technology, equipment, and applications.
• Recommend and implement new technology and processes.
• Provide project communication to team members, contract manufacturers, and stakeholders.
• Support product complaint investigations and reports.
• Perform other ad-hoc duties as assigned.

Essential Skills

• Bachelor's Degree in Mechanical Engineering or related field.
• Three years of experience as a Manufacturing Engineer.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills with the ability to assess problems or issues with manufacturing equipment.
• Extensive knowledge of production principles and techniques.
• Experience in plastic injection molding, automated assembly processes, and equipment specifications.
• Proficient with Microsoft Office Suite or related software.
• Proficient with computer-aided drafting (CAD) software.
• Experience creating, writing, and executing process/equipment IQ/OQ/PQ validations, including test method validations.

Additional Skills & Qualifications

• Six sigma black belt preferred.

Work Environment

The current site handles R&D, Packaging, and NRE's, providing a very innovative environment. The role requires travel to the Dominican Republic, Costa Rica, and Ireland, typically one week out of the month or one month off and 2 weeks at a time. The work involves setting up manufacturing lines, validating processes and equipment, and supporting a dynamic, fast-paced manufacturing setting.