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

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 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

The SetPoint Medical Product Development team is seeking a motivated, hardworking, and intellectually curious junior 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 in order to reach well-grounded conclusions that help guide design decisions.?

Position Responsibilities:

• Assist with troubleshooting of design issues, as they arise, for new and existing products
• Take ownership of assigned failure investigations for field issues or for manufacturing nonconformances
• For each investigation, document methods and findings, drive to completion, and provide recommendations to the team
• Assist with exploring design alternatives for new system components

Minimum Qualifications:

• B.S. Degree in Biomedical Engineering, or a B.S. Degree in a related STEM field
• Excellent analytical and critical thinking skills
• Excellent attention to detail
• Desire and ability to learn independently
• Comfort with data analysis and writing summary reports
• Strong writing skills
• Ability to work cross-functionally with other members of the organization
• Proficient with Microsoft Office products

Preferred Qualifications:

• Proficiency with using lab equipment (DMMs, oscilloscopes, function generators, etc.) to gather measurements
• Proficiency with programming in order to script experiments or to run data analyses (e.g., Matlab, Python, C, or VBA)
• Proficiency with reading production code (e.g., C or C#)
• Proficiency with reading schematics
• Proficiency with basic electromechanical assembly