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Research and Development Engineer

 

 

What we do:

 

CloudCath is redefining infectious disease remote monitoring for millions of patients globally. Our SF based team just closed a Series A funding round and we’re seeking excellent talent to join us leading this exciting mission.

Patients rely on implantable catheters to insert/drain fluid from their bodies on a regular basis to address multiple chronic/acute care conditions. Living with and managing this catheter in an outpatient setting without continuous medical supervision can be quite daunting for patients and results in multiple complications, most notable of which is infection origination.

Existing standards of care still rely on patients’ compliance with patient dependent non-data driven infection monitoring methods (such as the newspaper test), a state we find out-right unacceptable in 2020 with all this technological advancement at our disposal.

For our initial market – End Stage Renal Disease – the CloudCath device and real-time remote monitoring platform will enable physicians to remotely detect any originating infections within 12 hours from origination, a huge improvement from the 5 day existing standard of care average. We will save more than 3000 US lives annually from certain death (based on existing infection driven hospitalization mortality rates) and $Billions in unnecessary hospitalization expenditure.

 

What you do:

 

This is not a simple widget- the hardware comprises of electrical and mechanical hardware, firmware, data processing algorithms, a cloud database, and web application.  As an R&D Engineer, you will focus on designing and developing electro-mechanical systems and test equipment for manufacturing. You will characterize processes by designing studies, working with suppliers to prototype test samples, generating test data, and performing data analysis. You will execute rigorous documentation in developing a class II medical device and work under design controls and a quality management system.

In a lean startup, you will be expected to drive for impactful results every day. You will rapidly prototype, iterate fast, collaborate with the rest of our team using your excellent communication skills. Our experienced team will train and guide you, while giving you the best learning experience you could get by handing you the keys to be responsible for and become an expert in your domain.

 

Responsibilities

 

  • Mechanical design of parts and fixtures.
  • Design experiments with single and multiple variables.
  • Detailed documentation of experimental methodology, results, and analysis
  • Test equipment design.
  • Prototype designs.
  • Contribute technical aspects of risk management documentation.
  • Develop formal test methods, write and perform test protocols, and write reports that may be submitted to the FDA or other regulatory bodies.

 

Minimum qualifications:

 

  • Strong engineering fundamentals, and deep passion for engineering in education, internships and hobbies
  • BS in Mechanical Engineering, Biomedical engineering, or similar.
  • Mechatronics experience interfacing electrical and mechanical systems controlled by software.
  • Rapid prototyping experience using 3-D printing, machining and other methodologies.
  • Experience in experimental design. Detailed note taking, and documentation of experimental results.
  • Intermediate level in 3D mechanical design using Solidworks.
  • Matlab and/or Labview experience in characterizing electrical systems.
  • Experience with statistical data analysis in Excel, Matlab, or Minitab.
  • Strong communication skills- written reports, presentations, and oral communication.
  • Collaboration in team environments.
  • Strong team-player.
  • Adaptability to a dynamic work environment.

 

Preferred Qualifications:

 

  • MS degree
  • Experience with optics and light signals
  • Expertise in SolidWorks
  • Machining experience

 

Apply Now

Quality Assurance Manager

 

 

What we do:

 

CloudCath is redefining infectious disease remote monitoring for millions of patients globally. Our SF based team just closed a Series A funding round and we’re seeking excellent talent to join us leading this exciting mission.

 

Patients rely on implantable catheters to insert/drain fluid from their bodies on a regular basis to address multiple chronic/acute care conditions. Living with and managing this catheter in an outpatient setting without continuous medical supervision can be quite daunting for patients and results in multiple complications, most notable of which is infection origination.

 

Existing standards of care still rely on patients’ compliance with patient dependent non-data driven infection monitoring methods (such as the newspaper test), a state we find out-right unacceptable in 2020 with all this technological advancement at our disposal.

 

For our initial market – End Stage Renal Disease – the CloudCath device and real-time remote monitoring platform will enable physicians to remotely detect any originating infections within 12 hours from origination, a huge improvement from the 5 day existing standard of care average. We will save more than 3000 US lives annually from certain death (based on existing infection driven hospitalization mortality rates) and $Billions in unnecessary hospitalization expenditure.

 

Core Job Responsibilities:

 

  • Perform new product/device design control and ongoing quality engineering activities for Class II electrical/mechanical hardware, firmware, software and Class II disposable products.
  • Support cross-functional teams in developing and executing verification and validation protocols and reports.
  • Ensure completion and documentation of verification and validation activities, including traceability to requirements in compliance with applicable quality system regulations.
  • Facilitate the documentation of risk management using industry standard tools including FMEAs for systems, subsystems, manufacturing processes and clinical workflows to ISO 14971.
  • Provide Risk Management expertise in the evaluation and design of product, design validation and verification, complaint and nonconforming materials investigations and implementation of corrective and preventive action (CAPA), as required.
  • Hold responsibility for applying appropriate design controls, manufacturing controls, quality assurance techniques and controls, and statistical controls and methodology throughout the life cycle for respective products.
  • Utilize knowledge in statistical analyses to collaborate with Engineering team on the optimal approach for analyzing test data and determining Pass/Fail criteria, sample size determination and other applications requiring statistical knowledge
  • Maintain accountability for project timelines and deliverables to management.
  • Provide input and/or oversight for other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.

 

KNOWLEDGE AND SKILL REQUIREMENTS:

 

  • Bachelor degree in Engineering or Life Sciences required, master’s degree preferred.
  • 5 years of medical device industry experience required, May consider applicants with more senior level experience
  • High attention to detail and project management skills a must.
  • Knowledge of medical device regulations and standards (i.e., QSR, ISO 13485, ISO 14971, ISO 60601 series, ISO 62304, ISO 10993 series) required.
  • Experience in a full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service and post market analysis is critical.
  • Sound understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product servicing is necessary.
  • Excellent verbal and writing skills are required.

 

Apply Now

Apply Now

 

Clinical Manager

 

 

What we do:

 

CloudCath is redefining infectious disease remote monitoring for millions of patients globally. Our SF based team just closed a Series A funding round and we’re seeking excellent talent to join us leading this exciting mission.

 

Patients rely on implantable catheters to insert/drain fluid from their bodies on a regular basis to address multiple chronic/acute care conditions. Living with and managing this catheter in an outpatient setting without continuous medical supervision can be quite daunting for patients and results in multiple complications, most notable of which is infection origination.

 

Existing standards of care still rely on patients’ compliance with patient dependent non-data driven infection monitoring methods (such as the newspaper test), a state we find out-right unacceptable in 2020 with all this technological advancement at our disposal.

 

For our initial market – End Stage Renal Disease – the CloudCath device and real-time remote monitoring platform will enable physicians to remotely detect any originating infections within 12 hours from origination, a huge improvement from the 5 day existing standard of care average. We will save more than 3000 US lives annually from certain death (based on existing infection driven hospitalization mortality rates) and $Billions in unnecessary hospitalization expenditure.

 

What you do:

 

Responsible for operational support for all activities related to clinical study operations in the US and other countries, Provide technical expertise in protocol drafting/development and the implementation and monitoring of clinical studies at participating study sites according to Good Clinical Practices (GCP), Code of Federal Regulations (CFR) and standard operating procedures (SOPs). Ensure study documentation files are complete and audit-ready. Participate in study audits and respond to audit findings/recommendations. Contributes to the strategic implementation of the CloudCath clinical development program.

 

This role provides leadership within clinical operational activities to secure the successful completion of projects within the prescribed time frame and funding parameters. Prominent among these activities is the development and enforcement of new study protocols, clinical trial documentation, site-specific investigator brochures, site training materials and study-related contracts.

 

In a lean startup, you will be expected to drive for impactful results every day. You will rapidly prototype, iterate fast, collaborate with the rest of our team using your excellent communication skills. Our experienced team will train and guide you, while giving you the best learning experience you could get by handing you the keys to be responsible for and become an expert in your domain.

 

Core Job Responsibilities:

·        Contribute to the overall strategic direction for the development and implementation of clinical operations and processes;

·        Works with other members of the team to write protocols, informed consent forms, design case report forms, plan data analysis, generate specific criteria for safety reviews;

·        Assist in the selection and management of CROs and other providers of clinical research services;

·        Work collaboratively and effectively with investigators, coordinators, and other site staff;

·        Manage clinical site audit plans/procedures;

·        Oversee and/or conduct initiation, interim monitoring, and closeout visits and perform product accountability as needed;

·        Manage the review and resolution of discrepancies in clinical data with clinical sites;

·        Assist in maintaining compliance of investigational sites with SOPs, FDA and other appropriate regulatory guidelines;

·        Responsible for vendor management and implementation of clinical development trials.

·        Assesses requirements for submissions and programs to assure that all development activities are in compliance with all applicable regulations and guidelines;

·        Review and support product labeling and advertising activities as needed

·        Partner with project teams, other product development groups and the marketing function to define the requirements and specifications for new products, and to develop new product ideas and concepts.

 

Education, Knowledge and Skill Requirements:

 

·        5+ years direct clinical experience in medical devices

·        A minimum of a bachelor’s degree in science/health-related field

·        Experience with home healthcare or IoT connected medical devices preferred

·        Knowledge of GCP and FDA medical device regulations

·        Knowledge of electronic data capture systems and web-based clinical trial management tools;

·        Knowledge of research design, data analysis, and biostatistics;

·        Demonstrated problem-solving abilities in managing clinical sites and demonstrate tactfulness and diplomacy in dealing with study coordinators and physicians;

·        Excellent organizational skills and ability to juggle assignments without losing efficiency;

·        A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments

·        Good interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments

·        Demonstrated expertise in managing complex collaborations and teams in support of executing clinical trials effectively, including effective management of projects and timelines and interpretation/evaluation of clinical data

·        Excellent leadership capabilities; teamwork-oriented; interested in working in a multicultural and cross-functional environment

·        Demonstrated leadership experience, including excellent analytical, planning, and communication skills in a dynamic environment

·        Maturity, confidence, and credibility to advise and influence senior management

·        Demonstrated experience in effective planning, directing, and execution of clinical trials.

·        Able to travel 25% of the time

Apply Now

Apply Now