2463 South 3850 West
Salt Lake City, UT 84120
Please send all job applications to:
Cheryl Snapp Conner
Xenter, Inc. was founded by a team of experienced physicians and scientists, and a patient who is both a medical device inventor and entrepreneur. In 2017, our Founder envisioned a new generation of medical device technology utilizing the principles of Physical Intelligence (PI). He proposed this idea to leading physician-scientists and these unique partners came together to bring advanced medical interventions to underserved populations.
This is a unique opportunity with an exciting start-up company that will make a significant impact on interventional cardiology and the medical device community. We are a small, ambitious, and growing team. You must be highly motivated, an excellent self-starter, creative, proud of your work and believe in our vision. Your tasks will be varied, of a complex nature and the result of initiative or assignment. If you believe this is the kind of team that you would like to be a part of, and that you have the skills and experience that we need, please send us your resume.
Xenter, Inc. is developing new medical devices for cardiac care. This is an opportunity for an engineer with development and design for manufacturability experience on projects and/medical device products intended to treat/diagnose cardiovascular, peripheral, and neurological diseases. This person will develop new and/or improve processes ensuring that manufacturing processes meet requirements. This includes material procurement, prototype builds, manufacturing line optimization, and contribute to technology transfer from R&D to manufacturing.
Reports to: Director of Manufacturing Engineering
Areas of responsibility include the following:
- Execution of product manufacturing/industrialization activities including equipment implementation, process characterization, optimization, and validation.
- Process development – team up with R&D in product and equipment development.
- Implementation of equipment following Equipment Control requirements including IQ / OQ / PQ implementation.
- Providing and applying in-depth knowledge in design for manufacturability, reliability, methodical problem solving, and data driven decisions.
- Manufacturing readiness to ensure line setup, manufacturing documentation, materials, equipment, and tools are in place.
- This position may require travel up to 15%.
- BS Engineering degree.
- FDA QSR/cGMP and ISO13485.
- Proficient in SolidWorks.
- 5+ years experience in product and process development in a medical device industry with experience with guide wires, catheters/delivery systems, or equivalent devices.
- Design for manufacturing assembly.
- Equipment implementation in a regulated industry.
- Process validation – design of experiments, operational and performance qualifications
- FMEA – design, process, use.
- Knowledge in Medical product Design Controls.
- Execution of manufacturing of new products and process improvements.
- Knowledge operations metrics (cost, throughput, timelines, capacity etc.).
- Knowledge transfer – write and train engineers, technicians, and operators on work.