Manufacturing Engineer

Manufacturing EngineerThe Manufacturing Engineer provides hands-on engineering support to manufacturing operations by troubleshooting equipment, improving processes, executing validation activities, and maintaining manufacturing documentation in a regulated medical device environment. This role is highly practical and production-floor focused, requiring a strong mechanical aptitude and comfort working directly with equipment, tooling, and manufacturing processes. The engineer will balance hands-on work, such as equipment setup and fixture development, with authoring protocols, technical reports, and validation documentation to ensure compliant, efficient, and reliable manufacturing operations.ResponsibilitiesTroubleshoot, repair, and optimize manufacturing equipment, tooling, and production processes to ensure reliable and efficient operation.Provide hands-on engineering support for molding, assembly, packaging, and related manufacturing operations on the production floor.Design, build, modify, and document processing equipment, fixtures, tooling, and manufacturing systems to support production needs.Support the installation, maintenance, and qualification of manufacturing equipment, coordinating with maintenance and production teams as needed.Develop and execute equipment qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Author validation documentation, engineering studies, technical reports, engineering change orders, and manufacturing procedures in alignment with regulatory requirements.Conduct root cause investigations for equipment and process-related issues and implement effective corrective and preventive actions.Develop and execute test protocols to evaluate process improvements, equipment modifications, and manufacturing changes.Perform equipment requalification and process revalidation activities when changes or regulatory requirements dictate.Collaborate closely with Production, Quality, Manufacturing, and Regulatory teams to support manufacturing objectives and resolve issues.Develop, update, and maintain manufacturing documentation, including work instructions, operating procedures, process specifications, and engineering reports.Support and drive continuous improvement initiatives focused on safety, product quality, operational efficiency, and cost reduction.Train manufacturing personnel on new equipment, processes, and procedures to ensure safe and consistent operation.Maintain accurate records and documentation in compliance with FDA Good Manufacturing Practice (GMP) and ISO requirements.Work independently to prioritize and complete multiple engineering projects while providing daily support to ongoing manufacturing operations.Maintain a clean, safe, and organized work environment in all assigned areas.Be consistently present in the workplace during scheduled work hours to support production and engineering activities.Essential SkillsStrong hands-on mechanical aptitude and willingness to work directly with manufacturing equipment and tools.Experience troubleshooting manufacturing equipment and production processes in a regulated or structured environment.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, including equipment and process validation activities.Strong problem-solving skills with experience conducting root cause investigations and implementing corrective actions.Proficiency with Microsoft Office applications for documentation, data analysis, and reporting.Ability to communicate technical information clearly and effectively in both written and verbal formats.Ability to function effectively in an FDA-regulated and ISO-controlled manufacturing environment.Electromechanical experience and at least 1 year of technical or mechanical experience.Experience working in FDA GMP and ISO regulated environments.Ability to document work clearly and accurately, including test results and engineering findings.Additional Skills & QualificationsBachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or a related technical discipline is preferred.An equivalent combination of technical education and relevant experience may be considered in place of a specific degree.Experience with medical device, pharmaceutical, or other regulated manufacturing environments.Experience with equipment qualification and process validation, including IQ, OQ, and PQ activities.Familiarity with silicone processing, molding operations, or automated manufacturing equipment.Experience supporting Corrective and Preventive Actions (CAPA), change control processes, and continuous improvement initiatives.Experience with CAD software such as SolidWorks for designing fixtures, tooling, or equipment components.Experience with prototyping and test equipment setup in support of process or equipment development.Experience writing and maintaining standard operating procedures (SOPs) and related controlled documents.Strong interest in working in a small, stable organization with long-term growth opportunities and a leadership position in its industry category.Work EnvironmentThe role is based primarily on the engineering lab and cleanroom manufacturing floor, with frequent time spent on the production line, in laboratory areas, and in machine or maintenance shops. The position involves regular standing, walking, bending, and lifting in a manufacturing environment, as well as frequent use of hand tools and equipment. The engineer may occasionally lift up to 50 pounds and must be able to safely work around manufacturing equipment and machinery. The environment includes exposure to molding, assembly, packaging, and related operations in a regulated medical device setting governed by FDA GMP and ISO standards. Work hours are typically 7:00 a.m. to 4:00 p.m., and the engineer must be able to consistently work this schedule. The company offers a small, stable setting with a long-term opportunity and a culture that values safety, quality, and continuous improvement in a category-leading organization.Job Type & LocationThis is a Contract to Hire position based out of Ventura, CA.Pay and BenefitsThe pay range for this position is $31.25 - $38.46/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Ventura, CA.Application DeadlineThis position is anticipated to close on Sep 23, 2026.