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Manufacturing Engineer II

Company: Vertos Medical
Location: Aliso Viejo
Posted on: May 18, 2023

Job Description:


Manufacturing Engineer II


Aliso Viejo, CA

Job Id:


# of Openings:


Manufacturing Engineer II


Responsible for direct line support of the manufacturing process of Vertos products. A key member of the team resolving production issues and implementing product/process changes that directly improve the quality, cost, and supply of Vertos products to ensure that department goals are achieved.


  • Provide engineering support in the design, fabrication, development, installation, validation, and qualification of equipment/product that may include feasibility studies and/or documentation for proper implementation and operation of the equipment.
  • Provide support in the troubleshooting efforts for process/product issues. Summarize and draw conclusions from test results leading to effective technical resolution of process/product problems.
  • Identify and implement specified projects to reduce manufacturing costs, improve processes, increase product quality and reliability, and enhance process capability.
  • Coordinate resources to resolve process issues and implement changes.
  • Develop layouts and standards to support increased production output.
  • Support process development activities for new products in coordination with the R&D department.
  • Support Quality department in failure investigations.
  • Create DCNs (Document Change Notice) and technical reports for changes to drawings and procedures.
  • Comply with applicable FDA and international regulatory laws/standards.
  • Maintain the documentation necessary to ensure the consistent manufacture of Vertos products (processes, drawings, and shop floor paperwork).
  • Maintain and increase professional and technical knowledge by on-the-job training, attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
  • Support compliance with the company quality standards, FDA regulations and guidance, applicable EU Medical Device directives, applicable ISO standards, and other pertinent country specific medical regulatory requirements.
  • Perform special projects and other duties as assigned.



    • Bachelor's degree in mechanical, biomedical, engineering, or relevant technical field.
    • Minimum of two years of relevant experience.
    • Solid understanding of engineering principles - mechanical testing, heat transfer, statics
    • Knowledge of statistical techniques including descriptive/inferential statistics and DOE.
    • SolidWorks or other mechanical design program experience.


      • Experience in a manufacturing environment - designing, specifying, fabricating, assembling, measuring, validating, debugging machinery / product and manufacturing processes.
      • Process background (development, capability, optimization, validation) within a regulated industry.
      • Development of manufacturing documentation (work procedures, SOPs and process flow charts).
      • Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
      • Knowledge of molding and measurement equipment.


        • Ability to create and work from engineering drawings and/or specs, including tolerancing.
        • Ability to work effectively in a team environment.
        • Capacity to analyze problems and develop solutions.
        • Ability to handle multiple tasks effectively, consistently meet deadline, and lead projects.
        • Excellent verbal and written communication skills.
        • Organized and high level of attention to detail.
        • Strong analytical and problem-solving skills.
        • High level of English communication skills, including strong technical writing and verbal communication skills.
        • Comfortable working in a paperless environment.
        • Tech savvy: intermediate to advanced skills in Adobe and Microsoft Office applications, particularly MS Excel, MS Word, and MS PowerPoint; comfortable learning new technical systems as needed such as Box, Zoom, Slack, Smartsheet, and Concur.


          • Travel - Some travel to contract manufactures (
          • Physical Demand - While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Light physical effort required by handling objects of 20 pounds or more occasionally and/or up to 10 pounds frequently. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
          • Mental Demand - Moderate to high degree of concentration due to volume, complexity, and/or "pressure" of work. Ability to make critical thinking skills decisions under pressure.
          • Work Environment -

          • Potential exposure to bloodborne pathogens, pharmaceuticals, chemicals, needles, and sharps, and radiation (from x-ray / fluoroscopy and similar medical equipment).
          • When working in a home office environment, a dedicated office with minimal distractions which assures maximum privacy of computer screens to protect confidential and sensitive information is required; highspeed internet connectivity is required to work effectively.

            Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of all employees assigned to this position. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

            In addition to offering a great culture and work environment, Vertos also offers the following benefits:

            Health Insurance

            • Medical
            • Dental
            • Vision
            • Basic Life and AD&D
            • Supplemental Life & AD&D
            • Long-Term Disability
            • Health Care and Dependent Care Flexible Spending Accounts (FSAs)
            • Health Savings Accounts (HSAs) with employer contribution

              Paid Time Off

              • Paid Time Off
              • Paid Holidays
              • Jury/Witness Duty Leave
              • Bereavement Leave
              • Parental Leave Salary Continuation
              • Short-Term Disability Salary Continuation

                Other Benefits

                • 401(k) Retirement Savings Plan with employer match
                • Employee Assistance Program
                • Voluntary Accident, Critical Illness, Hospital Indemnity and Legal
                • Access to BenefitHUB discounts for 200,000 + vendors

                  Pay Range: $90,000 - $115,000 per year

                  Apply for this Position

Keywords: Vertos Medical, Aliso Viejo , Manufacturing Engineer II, Engineering , Aliso Viejo, California

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