About ReValve Solutions

ReValve Solutions Inc, based in Irvine, CA ( is dedicated to developing innovative treatment solutions for structural heart disease by delivering novel, transcatheter therapies that allow for long-term treatment options for patients.

Our immediate focus is the development of a transcatheter mitral valve technology that resolves mitral regurgitation (MR). MR impacts millions of people globally, leading to increased mortality and reduced quality of life. ReValve Solutions’ groundbreaking therapy addresses this overwhelming clinical need. ReValve Solutions is laser-focused on its mission to improve the lives of millions through the development of innovative transcatheter therapies.

Position Description

The Quality Engineer will play a critical role in the development of this novel therapy. By joining the ReValve team, this engineer will have the opportunity to work on cutting edge technology within the structural heart space. This role will have the opportunity to focus on various aspects of quality (design assurance and quality control) in the design, manufacturing, and testing of the ReValve Solutions transcatheter mitral valve. This role is also intended for a quality engineer who understands and can support the on-going development and implementation of a quality management system.

We are pushing the boundaries in structural heart development, and welcome those who face challenges head on and make data-informed decisions with the patient ultimately in mind. We value those who can apply a creative and hands-on approach to solving problems. Collaboration and innovation are at the heart of what we do, so the ability to communicate clearly and openly will be key to success in this role. We have assembled a world-class team to tackle some of the toughest problems in medical technology, and we hope you will join us.

Position Responsibilities

Quality Control : Develop manufacturing processes and process controls for in-house and supplier processes. Lead processes related to the receiving and inspection of components, management of inventory, and device assembly builds. Support inspections of incoming materials, in-process components, and finished products to ensure compliance with design requirements.

Design Assurance: Lead quality engineering activities related to product development of the ReValve devices. This will include working with a cross-functional team on defining design inputs/outputs, developing design verification test protocols/reports, performing risk management, supplier development, test methods, and defining inspection criteria. 

Risk Management: Participate in risk management activities for early product development to proactively identify potential issues, define requirements, and monitor quality related issues.

Quality Management System: Drive adherence of processes to defined quality management system procedures. Ensure internal quality systems meet required quality standards with a focus on continuous improvement.

Regulatory Compliance: Maintain compliance with regulatory requirements (e.g., FDA, ISO 13485) and company quality standards, ensuring adherence to Good Manufacturing Practices (GMP).

Equipment Calibration & Maintenance: Support the calibration, maintenance, and qualification of testing and production equipment for compliance with relevant standards.

Documentation: Prepare and maintain detailed and well-organized design history file, device master record, and device history record documentation. Lead the completion of technical summaries, inspection reports, non-conformance reports (NCRs), device investigations, and quality records. Ensure proper documentation of test results, test protocols, reports, and associated documentation for both design history and device history files.

Qualifications:

· Bachelor’s degree in engineering, science, or technical discipline required with 3 to 8 years of quality systems experience.

· Experience in quality control, design assurance, or related functions, preferably within the medical device industry.

· Strict attention to detail, with strong problem-solving abilities.

· Strong analytical skills with the ability to identify issues and interpret complex data.

· Ability to manage competing priorities in a fast-paced environment

· Demonstrated ability to work effectively in cross-functional teams and collaborate with manufacturing, engineering, and regulatory departments.

· Hands-on approach with a learning mindset

· In-depth knowledge of FDA regulations, ISO 13485, GMP, and other relevant standards.

Preferred Qualifications:

· Certification in Quality Engineering (e.g., CQE or CQA from ASQ).

· Familiarity with risk management tools and methodologies (e.g., FMEA, HACCP).

· Experience with root cause analysis tools (e.g., 5 Whys, Fishbone Diagram).

· Experience with validation of equipment, processes, or software used in a regulated environment.

· Experience with design and development of a class III medical device

· Experience in supplier management

Benefits and Pay

· ReValve Solutions provides a competitive compensation package which includes base pay, paid time off, comprehensive health benefits, 401k, and a development-focused work environment

· For California, the base pay for this position, which ranges from $90,000 - $140,000, will depend on qualifications, education, and prior experience