SetPoint Medical

Manufacturing Engineer

Bioelectronic Medicine

Valencia, California | 20-50 employees

Position Purpose

SetPoint Medical is a privately-held, clinical stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

As an instrumental member of the SetPoint Medical Operations group, you will be responsible for ensuring and improving the manufacturing processes and components of SetPoint’s novel medical device.

SetPoing Medical is a small, close group with a passion for developing the next major frontier in medicine. Located in Santa Clarita Valley, just north of Los Angeles in the beautiful Southern California Innovation Park – a hub for biomedical technology.

This position reports to the Director of Operations.

Key Responsibilities

  • Interface with Product Development, Operations, and Quality departments to ensure technology transfer for new products is performed in accordance with regulatory and manufacturing site requirements
  • Perform failure analysis by leading investigation team, analyzing and performing tests, documenting cause, and final outcomes
  • Assist in test plans, sampling plans, acceptance criteria, process validation, protocols, and reports
  • Facilitating documentation of functional, electrical, and mechanical drawing and specifications
  • Evaluate manufacturing processes by designing and conducting research activities; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with contract manufacturers by soliciting observations from operators
  • Assist in development of manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends
  • Provide manufacturing engineering information by answering questions and requests
  • Work with contract manufacturers to identify and implement process improvements
  • Focus on equipment calibration, maintenance, and management documentation
  • Perform acceptance activities such as RoHS, CAPAs, NCRs, QMS, process improvements, operator training
  • Develop test plans, acceptance criteria, process validation, protocols, and reports
  • Create and manage documentation of functional, electrical, and mechanical specifications

Skills & Experience Needed

  • Degreed in Engineering
  •  5+ years of manufacturing engineering experience
  • Class III medical device knowledge and experience
  • Ability to implement manufacturing processes and communicate effectively to team members
  • Familiarity with hardware specifications, manufacturing methods, and procedures.
  • Knowledge of manufacturing quality practices and standards
  • Ability to present technical information
  • Proficient in CAD solid modeling, CAD/CAM circuit design
  • Travel Requirements: Up to 30%

 

Who is SetPoint Medical?

SetPoint Medical is a privately held biomedical technology company dedicated to treating patients with debilitating autoimmune inflammatory diseases using bioelectronic medicine.

Founded in 2007, SetPoint Medical started exploring the scientific principles of stimulating the vagus nerve for treatment of autoimmune diseases based on Dr. Kevin Tracey’s pioneering discovery of the Inflammatory Reflex. In 2011, the company initiated proof-of-concept studies for treating rheumatoid arthritis using a modified off-the-shelf vagus nerve stimulator. The successful results of this study were published in the esteemed Proceedings of the National Academy of Sciences.

Their approach is intended to offer patients and providers a treatment alternative for rheumatoid arthritis, Crohn’s disease and other chronic inflammatory diseases with less risk and cost than drug therapy.

SetPoint Medical has raised more than $80 million to date in series A though D financing rounds with top tier VC and strategic investors

Current investors include:

  • Topspin
  • Medtronic
  • Boston Scientific
  • SightLine Partners
  • Morgenthaler Ventures
  • New Enterprise Associates (NEA)
  • GlaxoSmithKline’s Action Potential Venture Capital

View the company’s website

Our Technology

The emerging field of bioelectronic medicine aims to address unmet patient needs by delivering targeted digital doses to modulate physiological circuits for treatment of diseases historically treated with drugs.

SetPoint Medical is developing a novel bioelectronic medicine platform that stimulates the vagus nerve with digital doses of electricity designed to activate the cholinergic anti-inflammatory reflex to produce a systemic immunorestorative effect.

SetPoint researchers have invested more than four years collaborating with leading surgeons to design an implantable MicroRegulator and positioning device.

Their small, self-contained MicroRegulator generates precise electrical pulses using an integrated circuit, telemetry hardware and a rechargeable battery enclosed in a ceramic and titanium case. Physicians determine precise, automatic dosing through an iPad prescription application and patients recharge the pulse generator at their convenience using a comfortable wireless charger.

The company has published positive results from a first-in-human proof-of-concept trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS).

SetPoint is currently undergoing clinical studies in the United States for rheumatoid arthritis under FDA’s Investigational Device Exemption. In parallel, the company has conducted an additional successful proof-of-concept study in Crohn’s disease as well as promising pre-clinical research in multiple sclerosis. They expect to commercialize its bioelectronic medicine platform following FDA approval of its device.

Watch Kevin Tracey, neurosurgeon and SetPoint’s co-founder share the future of Bioelectronic Medicine

Leadership Team

Murthy Simhambhatla, PhD
Chief Executive Officer
David Chernhoff
Chief Medical Officer
Lusin Markaryan
Vice President of Regulatory Affairs
John Long
Director of Operations
Anna Gawlicka
Vice President of Clinical Affairs
Kevin Wilkin
Director of Quality Assurance