Manufacturing Engineer

Manufacturing Engineer

The Manufacturing Engineer plays a pivotal role in providing hands-on engineering support to manufacturing operations. This position involves equipment troubleshooting, process improvement, validation activities, and maintaining manufacturing documentation within a regulated medical device environment. The role requires a strong mechanical aptitude and the ability to work directly on the production floor with equipment, tooling, and manufacturing processes.

• Troubleshoot, repair, and optimize manufacturing equipment, tooling, and production processes.
• Provide hands-on engineering support for molding, assembly, packaging, and related manufacturing operations.
• Design, build, modify, and document processing equipment, fixtures, tooling, and manufacturing systems.
• Support installation, maintenance, and qualification of manufacturing equipment.
• Develop and execute equipment qualifications, including IQ, OQ, and PQ protocols.
• Author validation documentation, engineering studies, technical reports, engineering change orders, and manufacturing procedures.
• Conduct root cause investigations and implement corrective actions for equipment and process-related issues.
• Develop and execute test protocols to evaluate process improvements, equipment modifications, and manufacturing changes.
• Perform equipment requalification and process revalidation activities as required.
• Collaborate with Production, Quality, Manufacturing, and Regulatory teams to support manufacturing objectives.
• Develop and maintain manufacturing documentation including work instructions, operating procedures, process specifications, and engineering reports.
• Support implementation of continuous improvement initiatives focused on safety, quality, efficiency, and cost reduction.
• Train manufacturing personnel on new equipment, processes, and procedures.
• Maintain accurate records and documentation in compliance with FDA GMP and ISO requirements.
• Work independently to prioritize and complete multiple engineering projects while providing daily manufacturing support.
• Maintain a clean, safe, and organized work environment.

• Prototyping, protocol writing, electrical, and mechanical skills.
• Experience working in FDA GMP and ISO regulated environments.
• Electromechanical experience required with at least 1 year of technical/mechanical experience.
• Ability to document work and write technical reports.
• Strong hands-on mechanical aptitude.
• Experience troubleshooting manufacturing equipment and production processes.
• Ability to safely operate laboratory, machine shop, and maintenance equipment including drills, saws, presses, ovens, mixers, scales, calipers, and hand tools.
• Experience writing technical reports, protocols, procedures, and engineering documentation.
• Ability to read and interpret engineering drawings, schematics, and technical documentation.
• Familiarity with validation methodologies and documented engineering studies.
• Strong problem-solving and root cause investigation skills.
• Proficiency with Microsoft Office applications.
• Ability to communicate technical information effectively in both written and verbal formats.
• Ability to function effectively in an FDA-regulated and ISO-controlled environment.

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related technical discipline preferred.
• Equivalent combination of technical education and relevant experience may be considered.
• Medical device, pharmaceutical, or regulated manufacturing experience is preferred.
• Experience with equipment qualification and process validation.
• Familiarity with silicone processing, molding operations, or automated manufacturing equipment.
• Experience supporting CAPA, change control, and continuous improvement initiatives.
• Experience with CAD software such as Solid Works.

The work environment includes engineering labs and requires regular standing, walking, bending, and lifting in a manufacturing setting. Frequent use of hand tools and equipment is necessary, with occasional lifting of up to 50 pounds. The role involves working in…