JOIN OUR TEAM

 

Viseon is seeking talented persons to join our rapidly evolving, growing team!

 

Viseon is providing visualization solutions to maximize minimally invasive spine surgery and transform the surgical viewing and observing experience.  We are a well-funded, fast growing medical device company reimagining surgical experience through customer focus and state of the art technology products.

We are building the highest caliber organization with resolution and focus seeking individuals with intellectual curiosity, initiative, creativity, communication, problem solving and decision-making skills.  Our team works toward common objectives uniting resources to turn ideas into development, manufacturing and commercial products.

Viseon supports a culture of inclusiveness and diversity and is an equal opportunity employer.

 

Job Title: Inspector, Quality Control

Reports To: Quality Manager

Department: Quality

Manages Others: No

FLSA Status: Non-Exempt

Job Location: Irvine, CA

 

POSITION SUMMARY

Support Quality Control and Quality Engineering by performing tasks associated with quality for new product development and for operations.

 

ESSENTIAL FUNCTIONS OF THE POSITION

  • Perform tasks to complete incoming inspection of components

  • Perform in process/final inspection as needed

  • Perform shipment verification

  • Execute under the direction of quality engineering any validation or verification testing for new product development

  • Execute under the direction of quality engineering process validation protocols

  • Evaluate product returns from the field for root cause analysis

  • Perform other activities as required to support quality engineering

  • Update supervisor of work status or problems with recommendations for improvement or correction

  • Complete projects (including product enhancements) in a manner consistent with corporate objectives

  • Maintain, including pre-production quality assurance procedures, pre-clinical testing programs, and post production compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.

  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

QUALIFICATIONS & SKILLS

  • Experience with product development including use of lab equipment, developing concepts, feasibility studies and prototype design

  • Understanding of ISO / FDA Quality System Requirements and guidelines

  • Experience working in a clean room/environment

  • General knowledge of lab safety, MS Office and reading specification drawings

EDUCATION

Typically requires a high school diploma and a minimum of 2 – 4 years of related experience

Job Title: Sr. Software Engineer

Reports To: Director of R&D

Department: R&D

Manages Others: No

FLSA Status: Exempt

Job Location: Irvine, CA

 

POSITION SUMMARY

Translate user needs to design and develop software tools, GUIs and applications for new and  existing surgical visualization devices. Maintain software projects that support product development  and production. Collaborate with design, engineering, and production teams in a fast-paced and  innovative environment.

 

ESSENTIAL FUNCTIONS OF THE POSITION

  • Provide software engineering. Ability to code, test, document, and deploy software changes.

  • Maintain software projects, track issues, and control versions. 

  • Ability to work independently, organize tasks, and balance workload to meet department  objectives. 

  • Partner with project leads to generate software and firmware requirements.

  • Ability to interact, specify and be accountable for third-party resources during collaborative  projects. 

  • Develop verification methods to ensure repeatable product performance. 

  • Plan, prepare, and execute design control activities: write software documentation, develop  protocols, execute verification and validation testing, and report results. 

  • Participates as member on product development team as Production, Quality, and R&D support.  Performs special projects and other duties as assigned.

QUALIFICATIONS & SKILLS

  • Bachelor of Science Degree in Computer Science, Engineering, or related field; equivalent work experience acceptable. 

  • Experience in medical device electromechanical system development.

  • Fluent in C/C++ Programming Language.

  • Seasoned with Linux and Python bash scripting.

  • Embedded system development experience.

  • Able to utilize git-based management tools to coordinate software version control, Bug/Issue Tracking, and software documentation (Gitlab preferred).

  • Familiar with camera applications, image processing, graphical display, and video output (gstreamer, OpenCV, OpenGL, video4linux, OBS, or similar).

  • Experience with Serial/I2C devices; bonus for experience with MIPI camera serial interface and  working with Ser-Des chip sets.

  • Experience with SOM/COM embedded systems (Raspberry Pi, etc.).

  • Comfortable working in Linux environment (Yocto); bonus for experience with Buildroot.

  • Familiar with medical device quality systems, software life cycle processes, and basic safety – ISO 13485, ISO 9001, IEC 62304, IEC 60601-1.

  • Software V&V experience; Bonus for DevOps experience

  • Comfortable working with electronic hardware and reading schematics; ability to use basic  electronic equipment such as soldering stations, power supply, multimeter, oscilloscope, etc.

  • General knowledge of MS Office, PowerPoint, Excel.

WORK ENVIRONMENT / DEMANDS OF THE POSITION

Travel – Approximately 10% of work time may be spent traveling. 

Physical Demand – While performing the duties of this job, the employee is regularly required to  stand, walk, and sit for extended periods of time. Occasionally the employee may be required to lift  or move at least 25 pounds. 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. Expected to meet project deliverables that may require significant time  commitments and support.

Job Title: Production Supervisor

Reports To: Director of Operations

Department: Operations

Manages Others: Assemblers

FLSA Status: Exempt

Job Location: Irvine, CA

 

POSITION SUMMARY

Coordinate planning, conduct, and management of the manufacturing line, production team schedules, training, and metrics. Support purchasing, inventory management and R&D functions. Perform duties compliant to ISO, FDA or other standards included in the Company QMS.

ESSENTIAL FUNCTIONS OF THE POSITION

  • Schedule and issue documentation for all production builds and assure adequately trained personnel and materials are available to fulfill production requirements.

  • Ensure all operations personnel are trained to the applicable specifications and process parameters to properly assemble all Viseon devices.

  • Ensure a safe, professional, and respectful work environment.

  • Prepare and perform annual performance reviews for the production staff. Review and approve production staff timesheets.

  • Establish production metrics to monitor team performance and procedure steps and report quality measures on a timely basis.

  • Organize and maintain required storage areas for raw materials and production support.

  • Review and manage production equipment, including its maintenance and procurement.

  • Monitor product quality, react to quality incidents and coordinate corrective actions as necessary.

  • Conduct regular and ongoing informational and improvement team meetings.

  • Monitor compliance to safety rules, work expectations and housekeeping standards.

  • Maintain high level of visibility with production staff. Use hands-on approach to communicate and involve production staff in problem solving.

  • Perform daily audit to ensure employees are in adherence to manufacturing procedures.

  • Ensure the desired product quality levels are achieved through use of standard work and training to those standards, training in operation and inspection techniques, and use of tools/data.

  • Support and foster an environment of continuous improvement by encouraging production staff to challenge existing processes and implement solutions that enhance the overall effectiveness of the operation.

  • Performs special projects and other duties as assigned.

QUALIFICATIONS & SKILLS

  • Requires five (5) or more years’ experience in Medical Devices.

  • Requires two (2) or more years’ experience in Medical Devices in a supervisory role.

  • Good communication, personnel management, and time management skills.

  • Ability to communicate effectively and diplomatically with a wide variety of people.

  • Good computer skills in a variety of software programs such as Excel, Word, Outlook, and inventory management system that support the manufacturing environment.

  • Must be able to work the hours of the production team.

  • Must be able to work and be stationed in the cleanroom.

EDUCATION

Prefer BS degree in Engineering or Technical Sciences.

WORK ENVIRONMENT / DEMANDS OF THE POSITION

Travel – Approximately 5% of work time will be spent traveling.

Physical Demand – While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee may be required to lift or move at least 25 pounds. 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.