Manufacturing Engineer II
Company: Vertos Medical
Location: Aliso Viejo
Posted on: May 18, 2023
Manufacturing Engineer II
Aliso Viejo, CA
# 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.
ESSENTIAL FUNCTIONS OF THE POSITION
- 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
- Provide support in the troubleshooting efforts for
process/product issues. Summarize and draw conclusions from test
results leading to effective technical resolution of
- 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
- Develop layouts and standards to support increased production
- 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
- Maintain the documentation necessary to ensure the consistent
manufacture of Vertos products (processes, drawings, and shop floor
- 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.
EDUCATION AND/OR EXPERIENCE
- 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,
- Knowledge of molding and measurement equipment.
SKILLS, ABILITIES, AND CHARACTERISTICS
- 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.
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- 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
- 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
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:
- Basic Life and AD&D
- Supplemental Life & AD&D
- Long-Term Disability
- Health Care and Dependent Care Flexible Spending Accounts
- 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
- 401(k) Retirement Savings Plan with employer match
- Employee Assistance Program
- Voluntary Accident, Critical Illness, Hospital Indemnity and
- 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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