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

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

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.