Manufacturing Engineer

About the role

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.

Responsibilities

• 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.

Essential Skills

• 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.

Qualifications

• 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 SolidWorks.

Work Environment

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 manufacturing, laboratory, machine shop, maintenance shop, and cleanroom environments, with a focus on safety while working around manufacturing equipment and machinery.

Pay

The pay range for this position is $31.25 - $38.46/hr.

Job Type & Location

This is a Contract to Hire position based out of Ventura, CA. This is a fully onsite position.