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 design transfer, supply chain management and partner with suppliers to troubleshoot and find solutions to problems.
- Project Management and Scheduling – Establish and communicate project schedules, objectives, priorities and targets
- Supply chain strategy and development – Leads and assists with execution of supplier selection and development strategies
- Track manufacturing throughput, yield and quality issues (SPC) develop and implement programs address quality and/or throughput issues.
- Design Improvements & COGs Reduction – Leads design for manufacturability and design for assembly activities, implements process and design improvements
- Process Qualification and Validation – Coordination, execution and documentation (IQ, OQ, PQ)
- Writes test protocols and reports associated with transfer to manufacturing
- Change management and implementation – Life Cycle Engineering activities including Design Change Plan documentation and execution
- Failure Investigation and Root Cause Analysis
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.
- Degree in Electrical Engineering, Mechanical Engineering, or related
- 5+ years of in-house and outsourced electronics quality/manufacturing experience
- Expert in electro-mechanical Class II or Class III medical devices manufacturing and design controls – experience developing and executing master validation plans
- Minimum 5 years of experience in supply chain management – working with International suppliers
- Solid understanding of Mechanical Design, GD&T, Measurement Systems Analysis, Metrology, FAI
- Failure Analysis – Hands-on technical troubleshooting of field failures, SMT and box build manufacturing issues with demonstrated root cause analysis skills
- Familiar with statistical tools and analysis including Design of Experiments (DOE) and Statistical Process Control (SPC)
- Familiar with injection molding processes
- Experience with diagnostic equipment
- Experience with sterile disposable devices