Capstan Medical

Catheter-based heart valve replacement via robotics

Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours

Full-timeSanta Cruz, CA, USANo salary listedIn-person

About the Job

Requirements

Bachelor's degree in Engineering or a related technical field is required; a master's degree is a plus.
Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.
Experience working in a cleanroom manufacturing environment.
Experience with nonconforming material investigations and implementing effective corrective and preventive actions (CAPAs).
Strong understanding of quality management systems.
Ability to apply root cause analysis methodologies and solve problems.
Effective organizational and documentation skills, with attention to accuracy and precision in quality-related activities.
Strong communication and collaboration skills for cross-functional work and interaction with technicians, engineers, auditors, and third parties.
Ability to work independently in a fast-paced organization with competing priorities.

Responsibilities

Provide quality engineering support to the manufacturing line and support finished goods release for structural heart implant, delivery, and robotic devices.
Collaborate with Research and Development and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices.
Provide guidance on sterilization processes and validations to ensure product safety and compliance.
Facilitate sterilization activities, including batch release, sterilization validation, and coordination with third-party sterilizers.
Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.
Oversee product quality during all stages of production in a cleanroom manufacturing environment.
Lead and support investigations into nonconforming materials and products, working with cross-functional teams including Manufacturing and Engineering to identify root causes, ensure timely resolution, and implement corrective and preventive actions to prevent recurrence.
Participate in materials decision-making as a member of the Material Review Board.
Collaborate with Manufacturing and Engineering to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.
Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.
Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
Ensure compliance with relevant regulatory requirements, such as FDA Quality System Regulation and ISO 13485 standards.
Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.

The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line and supporting finished goods release for structural heart implant, delivery, and robotic devices.

Product and Operations Quality responsibilities include:

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices.
Provide guidance on sterilization processes and validations to ensure product safety and compliance.
Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers.
Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.
Oversee product quality during all stages of production in a cleanroom manufacturing environment.
Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
Participate in materials decision making as a member of Material Review Board
Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.
Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.

Documentation and Compliance responsibilities include:

Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.
Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.

Skills:

Strong understanding of quality management systems.

Excellent problem-solving skills and ability to apply root cause analysis methodologies.

Detail-oriented with effective organizational and documentation skills.

Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.

Attention to detail, with a focus on accuracy and precision in quality-related activities.

Ability to work independently in a fast-paced organization with competing priorities.

Requirements:

Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.

Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.

Experience working in a cleanroom manufacturing environment.

Experience with nonconforming material investigations and implementing effective CAPAs.

About the Company

Capstan Medical

Catheter-based heart valve replacement via robotics

Capstan Medical develops catheter-based heart valve replacement tools that use surgical robotics to guide valve implants through blood vessels, avoiding open-heart surgery. Its system combines implants, delivery catheters, and robotic navigation to treat mitral and tricuspid valve disease with minimally invasive techniques. It differentiates itself by integrating robotic guidance with catheter delivery to perform valve replacements without large incisions, aiming for safer, quicker recoveries. Its goal is to provide less invasive, effective treatments for structural heart disease.

Company size: 51-200
Company stage: Series C
Total funding: $141.4M
Headquarters: Santa Cruz, CA
Founded: 2020

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