The SetPoint Medical Operations team is seeking a motivated, hardworking, enthusiastic, and experienced manufacturing engineer to lead failure investigations efforts utilizing a cross-functional team to process and implement successful corrective actions. The ideal candidate will have a robust understanding of medical device systems engineering, and medical device manufacturing. This individual will be well versed in the root cause analysis techniques, manufacturing process controls, and able to communicate throughout the organization effectively. As specific tasks arise, the individual will need to gather relevant data, undertake independent research, formulate hypotheses, conduct experiments as needed, as well as draft reports for submission to quality and regulatory bodies. This individual will need to strike a balance between working on their own and leveraging the assistance of others to reach well-grounded failure investigation conclusions.

The Sr. Manufacturing Engineer will play a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Position Responsibilities:

• Lead and take ownership to completion of failure investigations for field issues, returned products, and manufacturing nonconformances ensuring adherence the SetPoint procedures
• Collaborate with Engineers, Suppliers, Clinical Specialists, Field Service Engineers Product Development, and Quality personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis
• Work with team to help analyze/resolve product quality problems and solve complex manufacturing problems, applying knowledge of production methods and quality improvements techniques improving existing manufacturing processes
• Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis
• Ensure compliance to SetPoint KPIs for timely closure of failure investigation and nonconformance activities
• Write formal reports, resulting in clear and accurate messaging about findings for a broad audience
• Provide frequent verbal and written updates of work-in-progress for various meetings
• For each investigation, document methods and findings, drive to completion, and provide recommendations to the team
• Advise management for trend and failure investigation process improvement
• Assist with other engineering activities as required

SetPoint Medical’s Purchasing Manager is responsible for purchasing activities related to the supply chain, tracking budget expenses, supporting vendor relationships, documentation, and production planning. The Purchasing Manager must be detail orientated and proactive in completion of job responsibilities to ensure timely purchasing activities and product compliance throughout the organization. This position will report to the Vice President of Operations.

Job Responsibilities:

• Negotiates contract terms, price, and lead times with suppliers prior to drafting purchase orders 
• Prepares purchase orders by verifying specifications and price, obtaining approval from requisitioning department, and complying with Approved Supplier List (ASL)
• Using product drawings and specifications, identify suitable suppliers, evaluate supplier capabilities, and determine best sourcing strategies
• Serves as a point of contact for all QMS purchasing requirements
• Verifies purchase requisitions by comparing items requested to released documentation
• Place supply and inventory orders
• Manages delivery schedule of all required materials and capital equipment ensuring delivery and quality commitments are met
• Verifies receipt of items by comparing items received to items ordered, resolves shipments in error with suppliers
• Ensuring materials and inventory is available and acceptable for appropriate phase activities
• Provides quarterly reporting to Senior Leadership Team detailing purchasing activity
• Perform all other duties deemed necessary to support SetPoint Medical 

The SetPoint Medical Product Development team is seeking a motivated, hardworking, and intellectually curious junior engineer to work on a sophisticated active implantable device and connected software systems. Programming responsibilities may include, depending on the Software Engineer’s skillset, any part of the software development stack from low-level embedded code to high-level cloud development. The software engineer will work closely with senior engineers to receive training and mentorship.

All candidates will be required to present a portfolio, either digital or printed, of relevant work experience, personal, and/or academic projects. Portfolios shall include screenshots of applications and websites the candidate has created, code examples, documentation examples, and/or anything else that highlights the candidate’s skills. Candidates that cannot present a portfolio need not apply.

Position Responsibilities:

Responsibilities will vary depending on the Software Engineer’s skillsets, but may include:

• Writing mobile applications for iOS using Swift, and Android applications using Java or Kotlin
• Writing Windows desktop applications in C# using WPF and UWP
• Authoring cloud services using C#
• Low-level embedded programming with C and C++
• Participate in planning, requirements analysis, architecture and specification design, and verification processes
• Actively communicate and engage with other departments (e.g., electrical and mechanical engineering, regulatory, quality, etc.) to develop a robust and controlled product  

Relocation:

Negotiable

Travel Requirements:

Minimal

Location:

Company Headquarters in Valencia, CA

Company Description:

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

 Please address all inquiries to careers@setpointmedical.com.

The SetPoint Medical Product Development team is seeking a motivated, hardworking, and intellectually curious engineer to assist with ensuring optimal design, robust functionality, and reliable manufacturing of its medical device system.

There will be a significant amount of on-the-job technical training under the guidance and mentorship of senior members of the team. The individual in this role is expected to take an initiative in learning about all aspects of the system. As specific tasks arise, the individual will need to gather relevant data, undertake independent research, formulate hypotheses, conduct lab experiments as needed, and present findings and recommendations to the team. The individual will need to strike a balance between working on their own and leveraging the assistance of others to reach well-grounded conclusions that help guide design decisions.

Position Responsibilities:

• Assist with design of implantable hermetic device
• Assist with the design of animal electrodes and devices for research purposes
• Assist in improvement of existing implantable device and processes
• Assist in designing assembly fixtures and tools involving tolerancing, selection of biocompatible material
• Creation of engineering drawings (using SolidWorks), BOMs, RI and FAI documents
• Submission of change order requests
• Training of production staff for building new products or applying new processes when transferring into manufacturing
• Working with contract manufacturers of implantable components and product, and test houses
• Writing design verification test plans, reports, and assembly procedures 
• Assist in process validation
• Assist in failure investigations for manufacturing
• Assist with exploring design alternatives for new system component  

Relocation:

Negotiable

Travel Requirements:

Minimal

Location:

Company Headquarters in Valencia, CA

Company Description:

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

 Please address all inquiries to careers@setpointmedical.com.

The Senior Clinical Research Associate (Sr CRA) independently manages and monitors investigational sites and has a thorough understanding of FDA, GCP, and ICH principles. This position oversees study execution from start-up to close-out at assigned study sites, including training, monitoring, and reporting in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures.  

The Sr CRA may act as a CRA team lead and shall be self-motivated, independent and able to work efficiently in a team environment. The Sr CRA mentors junior CRAs and participates in development of study protocol and materials. The Sr CRA will report to the Sr Manager, Clinical Operations.

Essential Functions

Include but are not limited to the following:

• Conduct site qualification, initiation, monitoring and close-out visits, submit timely reports, and assist with site selection
• Serves as the main contact for assigned study sites
• Ensure adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements
• Provide clinical support in the areas of implant procedure, basic troubleshooting, programming, and complaint reporting for the SetPoint System  
• Review source documentation, case report forms and data reports for accuracy, completeness, and timely submission
• Manage investigational product accountability 
• Communicate and work with site investigators and research staff to ensure proper reporting of adverse events and protocol deviations and escalate critical compliance issues to manager promptly
• Collect and transfer required site documents to the trial master file 
• Provide site updates at study meetings 
• Participate in the development of study documents (protocols, monitoring plans, case report forms, informed consent forms, study manuals) and EDC user acceptance testing
• Mentor and train CRAs in accordance with company procedures and ensure consistency with study practices, training, proctoring across CRA team members and clinical sites
• Review monitoring reports, trend compliance issues, create solutions and escalate to manager, as required
• May facilitate review meetings for study updates, adverse events, and protocol deviations
• Assist with routine quality audits to ensure that clinical sites maintain necessary study documentation and adhere to protocol requirement
• Attend relevant scientific meetings as directed

Location

This is a field position, requiring occasional visits to company headquarters in Valencia, CA 

The position may require travel 50-70% of the time, with periods of more frequent travel (up to 85%).

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure the delivery of high-quality development projects within approved program schedules. The Senior Quality Engineer will be responsible for the generation and review of all design control and risk management activities.

All candidates will be asked to describe in detail their individual as well as team contributions towards development and testing activities within a Class II/III medical device environment.

Job Responsibilities

• Provide functional input during development project planning to accurately assess resource and scheduling considerations
• Partner with Product Development and other cross-functional team members to define design input (i.e. Customer, System, Hardware, Software Requirements)
• Review and approve design input and design output documentation
• Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing
• Assist in the execution of dry runs and in oversight of official V&V testing
• Review and approve verification and validation test plans and test reports
• Represent as lead quality assurance team member in design review and phase review meetings
• Drive project/system level risk management deliverables (i.e. plans, Device Hazard Analyses, reports, and Risk Management)
• Review and approve other cross-functionally developed risk management deliverables(i.e. uFMEA, pFMEA)
• Review, assess, and approve all proposed changes (i.e. Engineering Change Orders, Deviations, etc.) to ensure proper level of testing supports implementation
• Verify development project documentation is in compliance with Company procedures
• Current working knowledge of 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and other standards as required
• Other projects as assigned

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure SetPoint Medical’s suppliers establish and maintain the high level of quality to be a Class III medical device supplier. The Senior Quality Engineer will be responsible for the initial evaluation, classification and ongoing monitoring of SetPoint suppliers.

All candidates will be asked to describe in detail their individual as well as team contributions towards supplier management activities within a Class II/III medical device environment.

Job Responsibilities

• Maintain the Supplier Management infrastructure; proposing and implementing improvements, as required
• Collaborate with cross functional groups in selection of new suppliers
• Perform thorough supplier audits of processes and QMS driving improvements, where necessary
• Collaborate with Product Development and Operations in production supplier development by evaluating and developing supplier processes through process and/or tooling validations, conducting supplier review meetings, and trainings as needed
• Drive corrective actions/supplier corrective action requests (SCAR) within the supplier management process
• Maintain all supplier quality records, including performance metrics and reports
• Current working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and other standards as required
• Other projects as assigned