About Us:
CloudCath is a small, fast paced, medical device startup, redefining infectious disease remote monitoring for catheter-based treatments.
Our initial focus is end stage renal disease patients that are on peritoneal dialysis. These patients rely on implantable catheters to insert/drain fluid from their bodies in home settings on a regular basis. Living with and managing this catheter in an outpatient setting without continuous medical supervision can result in multiple complications, including infection.
Existing standard of care relies on patients’ compliance with patient dependent manual infection monitoring methods such as visual inspection of their fluids. Our system, which comprises of a device and monitoring system, enables physicians to remotely detect the early signs of infection and other complications.
Early complication detection allows for earlier intervention, keeping patients out of the hospital, preserving their therapy longer, and avoiding morbidities from complications.
What you do:
You will take a patient-interfacing Class II medical device that has gone through clinical and technical validation, and support volume scale-up and commercialization activities. As a Sr. Manufacturing Engineer, you will lead process improvement projects, validations, test development, and product builds. You will support contract manufacturing activities, supply chain management and partner with suppliers to troubleshoot and find solutions to problems.
Who you are:
You thrive in taking new products to the market. You love applying your engineering background to solve problems. You enjoy the challenge of a complex electro-mechanical system with sophisticated firmware and optics. You thrive in opportunities to improve and scale a device design in a fast-paced startup environment with like-minded collaborators. You take a hands-on approach to overcome manufacturing scale-up challenges.
Minimum qualifications:
- Degree in Electrical Engineering, mechanical engineering, or related.
- Expert in electro-mechanical Class II or Class III medical devices manufacturing.
- Experience with Injection molding.
- Experience with PCBA manufacturing.
- Hands-on technical troubleshooting for manufacturing issues with demonstrated root cause analysis skills.
- Experience in supplier development and management.
- Experience establishing and driving operations key initiatives (i.e. second sourcing, cost reductions) and/or NPI/design transfer of Class II system components to Contract Manufacturers.
- Work with High Volume Contract Manufacturers to resolve existing production/quality/yield issues.
- Maintain BOM (Bill of Materials), MP (manufacturing procedure) thru the change order process.
- Author validation documentation (IQ/OQ/PQ/PPQ/MVP) to support the release of production equipment and tooling.
- Design tools and tooling to optimize the manufacturing lines.
- Working in accordance with Quality System procedures and actively enforces its objectives.
- Requires the ability to travel approximately 20% of the time.
Preferred Qualifications:
- Experience with diagnostic equipment.
- Experience with sterile disposable devices.