Duties and Responsibilities: Support the engineering team in development of new catheter-based medical devices and improvement of manufacturing processes in accordance with FDA and international regulations.
• Support day-to-day engineering activities including hands on laboratory and manufacturing support.
• Assemble medical device prototypes for product evaluation and testing.
• Perform testing using standard laboratory and inspection equipment (e.g. force testers, calipers, flow models, gauges, etc.)
• Build tools and fixtures utilizing experience with common shop tools.
• Support installation, troubleshooting, and maintenance of R&D equipment.
• Execute work according to approved procedures and provide feedback to update or generate new procedures as needed.
• Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations (21 CFR 820) and ISO 13485 requirements.
• Assure individual and group safety when conducting all activities.
• Maintain clear and effective communication with supervisors and cross-functional team members.
Education & Certifications:
• High school diploma or GED required
• Technical degree programs/certifications desired
Work Experience:
• 1-3 years experience working in a lab or medical device manufacturing environment.
Knowledge, Skills & Abilities:
• Mechanical aptitude
• Experience with physical and mechanical testing. ISO and ASTM testing experience preferred.
• Ability to read and interpret engineering drawings.
• Basic knowledge/capability of SolidWorks is preferred.
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices
Physical Requirements:
• Able to use a microscope and operate machinery.
• Must be able to lift and carry up to 40 lbs.
TriSalus Life Sciences® was established to develop and commercialize disruptive drug delivery technology for the treatment of liver and pancreatic tumors. Our proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach, which has been used in over 18,000 procedures, improves therapy penetration by modulating pressure and flow to overcome the intravascular barriers to therapy delivery. This is a significant step forward in the treatment of liver and pancreatic tumors.
Along with effective drug delivery, we recognize that overcoming immunosuppression in these organs is also important to successful immunotherapy. Because of this, we’ve launched a platform approach that integrates our innovative device technology with a proprietary therapeutic. In 2020 we acquired nelitolimod, an investigational toll-like receptor 9 (TLR9) agonist with the goal of improving outcomes for liver and pancreatic cancer patients. In our phase 1 studies, nelitolimod has demonstrated reversal of immunosuppression and promotion of responses to checkpoint inhibitors.1,2,3,4
In addition to our in-market TriNav® Infusion System and our 510(k) cleared pancreatic delivery system, we are now moving forward with a range of Phase 1 clinical trials in primary liver and pancreatic cancers. We believe we have the potential to transform the treatment of these diseases for patients with limited treatment options.