Product Development Coordinator

4 weeks ago

Aliso Viejo, United States Vertos Medical, Inc Full time
Job DescriptionJob DescriptionDescription:

Responsible for supporting the product development team with improvements of Company products. An integral member of the Company's Product Development team and participates in developing engineering documentation, CAD designs, prototypes, lab and bench testing, design verification, validation.

  • Provide engineering support to the design and development of Company products, ensuring compliance with industry standards and regulations.
  • Develop prototypes and models to validate design concepts and conduct testing to ensure that products meet performance and safety requirements.
  • Support the development of and execute test protocols, including mechanical testing, stress testing, and performance evaluation, documenting results and making design improvements.
  • Collaborate with cross-functional teams to troubleshoot process/product issues associated with device design and manufacturing issues;
  • Perform engineering calculations, simulations, and finite element analysis to assess design performance, structural integrity, and reliability under the supervision of an engineer or manager.
  • Evaluate materials for product components, considering factors such as biocompatibility, durability, and sterilization requirements.
  • Comply with applicable FDA and international regulatory laws/standards.
  • Prepare and maintain comprehensive design documentation, including design history files, specifications, and technical reports.
  • 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.
Requirements:

EDUCATION AND/OR EXPERIENCE


Required

  • Completion of two years of a Bachelor of Science degree in mechanical or biomedical engineering, or relevant technical field.
  • SolidWorks or other CAD software experience.
  • Understanding of engineering design principles.
  • Demonstrated strong mechanical aptitude.


Bonus

  • Experience working in a process background (development, capability, optimization, validation) within a regulated industry.
  • Knowledge of medical device regulations.
  • Experience working in the development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
  • Knowledge of molding and measurement equipment.


SKILLS, ABILITIES, AND CHARACTERISTICS


  • Ability to work effectively in a team environment.
  • Capacity to develop solutions to problems with analytical and technical skills.
  • Ability to handle multiple tasks effectively, consistently meet deadlines.
  • Excellent verbal and written communication skills.
  • Organized and high level of attention to detail.
  • High level of English communication skills, including strong technical writing and verbal communication skills.
  • Comfortable working in a paperless environment.
  • Have an attitude of curiosity and a desire to learn
  • 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 (Distributed Workforce) – This position will work in the office a minimum of three (3) days a week at our corporate office located in Aliso Viejo, CA. Some travel to contract manufactures (

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