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/or 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 and assess all proposed changes (i.e. Change Requests, Special Rework Instructions) 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, ISO 13485, ISO 14971, and other standards as required
• Other projects as assigned

Minimum Qualifications

• Bachelor's degree in Engineering, related technology, or equivalent experience required; MS preferred
• Medical device industry experience of 5 or more years required
• Experience with Class III sterile, implantable electromechanical devices utilizing microcontrollers strongly preferred
• Demonstrated individual and team-based contributions towards development and testing activities
• GD&T skills and knowledge is desirable
• Quality System Knowledge including 21 CFR 820, ISO 13485, and ISO 14971
• Demonstrated skills in statistical analysis

Required Skills and Abilities 

• Work collaboratively and effectively on cross-functional teams to meet development project goals
• Ability to effectively support multiple high priority deliverables at once
• Outstanding written and oral communication skills
• High attention to detail
• Ability to review, analyze, summarize, and interpret data to draw conclusions and make appropriate recommendations and decisions
• Must be able to write clear, understandable written reports, and give oral presentations
• Strong organizational and time management skills
• Ability to take a creative and proactive approach when considering resolutions and/or alternatives
• Effective interpersonal/communication skills

Company Description

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

Relocation

Not available

Location

Company Headquarters in Valencia, CA

Estimated Hire Date: October 2020

Status: Accepting Applications

Apply Now

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

Minimum Qualifications 

• BS in Engineering or Scientific field (MS preferred), with 5+ years of work experience in engineering, quality assurance and/or supplier quality
• Experience working in the medical device or pharmaceutical industry
• Experience in outsourced contract manufacturing environment is preferred
• Experience with Process Validations and/or Test Method Validations (i.e., IQ, OQ, PQ, and/or TMV)
• Quality System Knowledge including 21 CFR 820, ISO 13485, and ISO 14971

Required Skills and Abilities 

• Work collaboratively and effectively on cross-functional teams to meet compliance objectives
• Ability to effectively support multiple high priority deliverables at once
• Outstanding written and oral communication skills
• High attention to detail
• Ability to review, analyze, summarize, and interpret data to draw conclusions and make appropriate recommendations and decisions
• Must be able to write clear, understandable written reports, and give oral presentations
• Strong organizational and time management skills
• Ability to take a creative and proactive approach when considering resolutions and/or alternatives
• Effective interpersonal/communication skills

Company Description

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

Relocation

Not available

Location

Company Headquarters in Valencia, CA

Estimated Hire Date: October 2020

Status: Accepting Applications

Apply Now

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure quality design and manufacture of Class III medical devices. The Senior Quality Engineer will be responsible for all quality aspects of material control, process validations and process improvements.

All candidates will be asked to describe in detail their individual as well as team contributions towards risk evaluation/control and process validations within a Class II/III medical device environment.

Job Responsibilities

• Maintain the Process Control infrastructure; proposing and implementing improvements, as required
• Collaborate with cross functional groups in development, review and approval of validation plans and reports
• Participate in risk management activities, specifically leading Process Maps development and process Failure Modes and Effects Analysis
• Review and approve all process changes (Engineering Change Orders, Deviations, etc.) certifying that all changes have been correctly implemented and tested
• Support supplier quality and production control through participation in the Receiving Inspection (RI) and Nonconformance Review (NMR) processes
• Participate in Quality Review Board (QRB) meetings, identifying non-conformance trends, performing technical investigations, and implementing corrective action programs to resolve recurring quality problems
• Current working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and other standards as required
• Other projects as assigned

Minimum Qualifications

• BS in Engineering or Scientific field (MS preferred), with 5+ years of work experience in engineering, quality assurance and/or supplier quality
• Experience working in the medical device or pharmaceutical industry
• Experience in an outsourced contract manufacturing environment is preferred
• Process and/or measurement system validation experience required
• Demonstrated skills in statistical analysis
• Proficient with the operation of Coordinate Measuring Machines (CMMs) is highly desirable
• Quality System Knowledge including 21 CFR 820, ISO 13485, and ISO 14971

Required Skills and Abilities 

• Work collaboratively and effectively on cross-functional teams to maintain infrastructure
• Ability to effectively support multiple high priority deliverables at once
• Outstanding written and oral communication skills
• Capable of leading Continuous Improvement or Corrective and Preventive Action teams, and/or working with suppliers to resolve product quality issues
• High attention to detail
• Ability to review, analyze, summarize, and interpret data to draw conclusions and make appropriate recommendations and decisions
• Must be able to write clear, understandable written reports, and give oral presentations
• Strong organizational and time management skills
• Ability to take a creative and proactive approach when considering resolutions and/or alternatives
• Effective interpersonal/communication skills

Company Description

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

Relocation

Not available

Location

Company Headquarters in Valencia, CA

Estimated Hire Date: October 2020

Status: Accepting Applications

Apply Now

None SetPoint Medical is seeking a highly motivated and self-driven Computer Science, Software Engineering, or Computer Information Systems student to work on a sophisticated active implantable device for their co-op or externship. Responsibilities may include, depending on the student’s skillset, any part of the software development stack (from low-level embedded code to high-level cloud development). This is a full-time, off-site position. Co-op position up to 1 year.

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Position Description

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

Education, Experience and Skills Requirements

• Bachelor’s Degree in science/health-related degree (Health Science, RN, or advanced degree preferred)

• Minimum 5 years of experience in medical device or pharmaceutical industry directly supporting and monitoring investigational clinical studies

• Thorough knowledge of CFRs, IDE, PMA, GCPs and ICH Guidelines

• Demonstrate strong interpersonal and organizational skills

• Have excellent verbal and written communication and critical thinking skills along with a positive attitude

• Able to work in a fast-paced environment and complete tasks independently and efficiently with a high attention to detail and accuracy

• Self-motivated, assertive and able to function independently and as part of a team

Other Requirements

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

Location

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

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Position Description

The Senior Field Clinical Engineer (Sr FCE) is responsible for proctoring implant procedures, providing ongoing training to surgeons and clinical sites on the use of the SetPoint system in accordance with the Instructions for Use and building effective relationships between paired rheumatologists and surgeons. The Sr FCE in collaboration with the Clinical Research Associate (CRA) supports assigned clinical sites during study start-up activities, site initiation visits, and follow-up visits. The Sr FCE will report to the Sr Manager, Clinical Operations.

Job Responsibilities

Include but are not limited to the following:

• Support implant procedure, programming, troubleshooting, and complaint reporting at clinical study sites to ensure optimal system performance and maximum patient safety

• Demonstrate outstanding product knowledge and train physician investigators and their support team on the SetPoint System

• Provide feedback from cases and assist in developing future training materials and presentations for surgeons and site personnel

• Assist with site selection by identifying and paring rheumatologists with surgeons

• Support site qualification, initiation and monitoring activities

• Create clinical study materials, such as presentations, work instructions and product training

• Review source documentation and data reports for accuracy and completeness and assist with management of investigational product accountability

• Ensure proper reporting of adverse events, protocol deviations, and device deficiencies and escalate to management in a timely manner as applicable

Minimum Qualifications

• Bachelor's or master’s degree in Biomedical Engineering or an equivalent scientific discipline, with a minimum of 5 years of directly related experience with active implantable devices and therapy programming

• Proven experience developing and maintaining strong relationship with physicians and their practices

• Practical knowledge of engineering principles, human anatomy, physician and hospital practices, and operating room etiquette

• Experience with neurological active implantable devices and working with neurosurgeons is strongly preferred

• Prior experience providing didactic or in vivo surgical training

• Experience conducting clinical trials with medical devices

• Knowledge of Good Clinical Practice

• Ability to fulfill and maintain background and health requirements necessary to gain access to clinical study centers, including operating rooms

• Motivated self-starter with ability to work independently and collaboratively in a diverse cross-functional team environment

• Excellent verbal and written communication, presentation and training skills

• Ability to think quickly on your feet and respond to needs as they arise

Other Requirements

• The position may require travel 60-70% of the time, with periods of more frequent travel (up to 90%)

Location

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

Apply Now

Position Description

The Clinical Research Associate II (CRA II) is responsible for effectively managing investigational sites in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures. This position oversees study execution from start-up to close-out at assigned study sites, including training, monitoring, and reporting. The CRA II reports to the Senior Manager of Clinical Operations.

Essential Functions

Include but are not limited to the following:

• Conduct site qualification, initiation, monitoring and close-out visits and submit timely reports

• 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

• Respond to any protocol-related issues and timely escalate to management

• Collect and transfer required site documents for trial master file

• Provide site updates at study team meetings

• Participate in development of clinical study materials, such as source documentation, work instructions, patient recruitment materials and product training

• Attend relevant scientific meetings as directed

Education, Experience and Skills Requirements

• Bachelor’s Degree in science/health-related degree (Health Science or RN preferred)

• Minimum 2 years of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies

• Working knowledge of CFRs, IDE, PMA, GCPs and ICH Guidelines

• Demonstrate strong interpersonal and organizational skills

• Have excellent verbal and written communication skills along with a positive attitude

• Able to work in a fast-paced environment and complete tasks independently and efficiently with a high attention to detail and accuracy

Other Requirements

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

Location

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

Apply Now

Position Description:

The In-House Clinical Research Associate II (iCRA II) is responsible for supporting clinical operation teams and effectively coordinating in-house activities associated with study conduct. This position supports the day-to-day operations associated with the execution of company’s clinical trials. iCRA II is responsible for managing clinical master file and proper filing of study and site documentation in compliance with protocols and all applicable regulations to meet overall clinical and company objectives for timely execution of clinical studies in accordance with the highest ethical standards and scientific rigor. The Clinical Research Associate II (In-House) position reports to Manager of Clinical Operations.

Job Responsibilities

Include but are not limited to the following:

• Support study start­up activities at sites by finalizing Informed Consent Form language, collecting essential study documents and delivering regulatory and patient binders, training tools and other necessary study supplies

• Build and manage eTMF per clinical procedures and in compliance with GCP guidelines, FDA regulations and IRB requirements

• Maintain clinical central files

• Support IRB submissions, amendments and annual reports, as applicable

• Maintain site contact information, coordinate site and patient payments, and create patient follow-up schedules for distribution

• Can be the primary sponsor contact for clinical investigational sites on the matters related to contracts, budgets, invoicing, and IRB submission

• May contribute to the development and improvement of company procedures, processes, and templates towards continuous quality improvement.

• Assist with reconciliation of investigational products and supplies

• Support audit readiness by maintaining proper clinical trial documentation, conducting routine internal clinical file assessments and participating in audits

• Provides monitoring visit support as needed, e.g., helps with the visit preparation and supports site qualification, site training, routine monitoring and close out visits, as well as monitoring visit reporting, if needed

Minimum Qualifications

• Associates Degree in science/health-related degree (Health Science or RN preferred) or equivalent combination of experience and education

• 2-3 year of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies

• Working knowledge of CFRs, IDE, NDA, GCPs and ICH Guidelines

• Demonstrate strong interpersonal and organizational skills

• Have excellent verbal and written communication skills along with a positive attitude

• Able to work in a fast-paced environment and complete tasks efficiently with appropriate direction, with a high attention to detail and accuracy

Other Requirements

• Position may require occasional travel (primarily domestic).

Location

The position will be located at company headquarters in Valencia, CA. Remote position will be considered based on experience.

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Position Description

The Manager of Clinical Operations provides leadership, strategic planning, effective implementation, ongoing management of clinical operations to ensure seamless execution of company’s clinical trials. This position manages the in-house team of CRAs by recruiting exceptional talents, providing direction to stretch their skillsets and advance in their careers and fostering exceptional teamwork. The Manager of Clinical Operations develops, drives and supports initiatives to enhance operational efficiency and excellence. The position ensures compliance of the clinical operations with Good Clinical Practices, study protocols and all applicable regulations to meet the company and clinical departmental objectives. The Manager of Clinical Operations reports to the Vice President, Clinical Affairs.

Job Responsibilities

Include but are not limited to the following:

• Provide leadership, strategic planning, direction and implementation of clinical operations standard operating procedures and best practices within the team and ensure compliance

• Define and implement strategy for execution of clinical trials. Responsibilities include planning and management of study timelines, budgets, resources, and vendors

• Ensure timely site selection and operational excellence by ccommunicating effectively with clinical investigators and site staff to support study enrollment and execution

• Manage study start-up activities related to timely execution of site contracts, budgets and IRB approvals

• Ensure development, execution and tracking of site budgets, contracts, and payments

• Provides day-to day support to field clinical operations with documentation

• Manage in-house CRAs by mentoring, coaching, delegating, establishing clear goal, evaluating their performance, guiding their career development and fostering exceptional teamwork

• Demonstrate strong leadership competencies. Make decisions and charts course through careful evaluation of risks and benefits with limited information

• Anticipate potential problems within clinical operations and create contingency plans accordingly. Elevate potential changes to management

• Oversee the implementation and maintenance of study-specific Trial Master File

• Oversee the Electronic Clinical Document Control (eCDC) procedures and process

• Provide timely status updates on study progress to clinical team and management by conducting meetings and creating presentations with information on eTMF and eCDC status, audit readiness and other relevant matters

• Manage IRB submissions, approvals and renewals of study protocols, ICF and other study-related materials

• Determine and oversee site investigational product requirements and accountability

• Ensure in-house team’s compliance with all applicable SOPs, regulations and guidelines

• Assist with routine quality audits as applicable

• Provide field support with site qualification, start-up and management, as needed

• Organize and manage internal team meetings, investigator meetings and other trial-specific meetings

Minimum Qualifications

• Bachelor’s Degree in scientific discipline (RN or advanced degree preferred) or equivalent combination of education and experience

• A minimum of 5 years’ experience in the medical device or pharmaceutical industry, managing clinical operations, programs, projects and teams, including identifying, recruiting and developing high performance CRAs

• Strong performance management skills to build organizational capabilities.

• Recognized leader in standard business procedures (SOPs and Global regulations) and the application of procedures to the business. Considered a Subject Matter Expert and key contributor to initiatives

• Working knowledge of CFRs, IDE, GCPs and ICH Guidelines

• Can foster creative thinking, innovation, knowledge sharing and reasoned risk-taking

• Excellent presentation, verbal, written communication skills

• Prior clinical trial experience with chronic inflammatory diseases and their treatments is preferred

• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles

• High degree of professionalism, ethics and integrity with the ability to serve as a credible and passionate champion for SetPoint Medical projects

• Able to complete tasks independently and efficiently with attention to detail and in a timely manner

Other Requirements

• The position may require occasional travel

Apply Now