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: Process Engineer

Reports To: Operation/Production Manager

Department: Operations

Manages Others: No

FLSA Status: Exempt

Job Location: Irvine, CA

 

POSITION SUMMARY

The Process Engineer will provide support to manufacturing to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Identify opportunities for re-design/design of basic equipment, COGs reductions, tools, fixtures, etc. to improve manufacturing processes.

 

ESSENTIAL FUNCTIONS OF THE POSITION

  • Support all current and new product introductions

  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

  • Work closely with Research and Development, Quality Assurance and Management to develop processes and prevent problems with products and tooling/fixtures

  • Review manufacturing documentation and processes and identify opportunities for improvements related to costs, quality, safety and productivity

  • Design, document and perform IQ/OQ/PQ and test method qualifications for equipment and processes

  • Monitor performance of equipment, machines and tools and corrects equipment problems or process parameters

  • Ensure all manufacturing safety regulatory policies and procedures are implemented and maintained at all times

  • Stay informed concerning new manufacturing technologies and equipment in order to manufacture and reduce cost through efficiencies

  • Ensure vendors/subcontractors are manufacturing components and assemblies according to product specifications

  • Participate in CAPA’s and NCMR’s including determining and eliminating issues in the manufacturing process and supply chain

 

QUALIFICATIONS & SKILLS

  • Experience with medical device product development through commercialization effort

  • Experience working in a cleanroom

  • Understanding of ISO / FDA Quality System Requirements and guidelines and cGMPs

  • Ability to plan and schedule multiple projects and tasks

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

  • Excellent communication skills

  • Solidworks or equivalent CAD software

  • Rapid prototyping experience

  • Skills include but not limited to general electronic soldering/assembly, fabrication, adhesives, and packaging

 

EDUCATION

Bachelor’s degree in mechanical engineering or > 3 years’ experience in manufacturing engineering for medical devices