Manufacturing Engineer Ii Jobs

POSITION SUMMARY

ESSENTIAL FUNCTIONS OF THE POSITION

• Identify and implement specified projects to reduce manufacturing costs, improve processes, increase product quality and reliability, and enhance process capability.
• Maintain the documentation necessary to ensure the consistent manufacture of Vertos products (processes, drawings, and shop floor paperwork).
• Support Quality department in failure investigations.
• 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 process development activities for new products in coordination with the R&D department.
• 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.
• Create DCNs (Document Change Notice) and technical reports for changes to drawings and procedures.
• Perform special projects and other duties as assigned.
• 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.
• Comply with applicable FDA and international regulatory laws/standards.
• Coordinate resources to resolve process issues and implement changes.
• 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.
• Develop layouts and standards to support increased production output.

EDUCATION AND/OR EXPERIENCE

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

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

SKILLS, ABILITIES, AND CHARACTERISTICS

• Strong analytical and problem-solving 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.
• Capacity to analyze problems and develop solutions.
• Ability to work effectively in a team environment.
• Ability to handle multiple tasks effectively, consistently meet deadline, and lead projects.
• High level of English communication skills, including strong technical writing and verbal communication skills.
• Ability to create and work from engineering drawings and/or specs, including tolerancing.
• Excellent verbal and written communication skills.
• Organized and high level of attention to detail.

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

• 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.
• 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.
• 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.
• 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.
• Travel – Some travel to contract manufactures (<15%)
• Potential exposure to bloodborne pathogens, pharmaceuticals, chemicals, needles, and sharps, and radiation (from x-ray / fluoroscopy and similar medical equipment).