Senior, Design Quality Engineer (Oxygen and Sleep)

Dublin, VA - USA

Monthly Salary: Not Disclosed

Posted on: 23-10-2025

Vacancies: 1 Vacancy

Job Summary

POSITION:Senior Design Quality Engineer (Oxygen and Sleep)

FULL-TIME/PART-TIME:Full Time

LOCATION: (Dublin OH)

React Health is a fast-paced growth-driven manufacturer and distributor of medical equipment dedicated to supporting patients caregivers physicians and healthcare providers. With a focuson respiratory and sleep health sectors we offer a comprehensive range of products and services across acute care non-acute care and home medical equipment. By integrating manufacturing and distribution React Health addresses the needs of both undiagnosed individuals and those requiring therapy after diagnosis particularly within the sleep and respiratory care sectors.

GENERAL SUMMARY
The Senior Design Quality Engineer (Oxygen and Sleep) will work directly with the Design teams to support new product development and sustaining of React Healths oxygen and sleep therapy devices ensuring risk management of new and existing product design. The Senior Design Quality Engineer assures products conform to quality standards and establishes compliance with the quality system. The Senior Design Quality Engineer is also responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

QUALIFICATIONS

7 years of experience or equivalent experience in Medical Device Design control and the application of ISOCFR820 ISO13485 IEC62304 IEC 62366 IEC 60601
Experience with new design (NPD) design transfer design changes and sustaining of mechanical and software driven devices.
Experience with IEC 62304 / 82304 Medical device software - Software life-cycle processes
Experience with test method development and the validation of those test methods
Experience with risk management file creation and updates
Bachelors degree in engineering life sciences or related field

Preferred Education

Masters degree in engineering or life science discipline

Preferred Experience

Experience working with electronic circuit boards and cable assemblies
DHF (Design History File) remediation when moving from one design control system to another
Experience in development of SaMD (Software as a Medical Device)
Design for Six Sigma
Familiarity with electronic quality management systems
Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people

Physical Demands

Requires normal visual acuity and hearing.
Typically employees sit comfortably to do their work interspersed by brief periods of standing walking bending carrying papers and books and extensive periods requiring the use of computer terminals to accomplish work objectives.
Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
Additional skills may be required to perform additional task(s) specific to work location department or line of business.

Working Conditions

Predominantly operates in an office environment and research and development laboratory as required

DUTIES AND ESSENTIAL FUNCTIONS
Each Employee consistently demonstrates the following essential functions:

Initiate review and/or approve Engineering Change Orders
Perform and document design controls for new products
Develop and maintain risk management files
Support specification development
Identify and implement improvements to the design control program
Coordinate and perform test method validation testing
Support verification and validation testing
Applies statistics to make business decisions.
Ability to conduct failure investigation and root cause analysis.
Identify and implement improvements to QMS
May support internal audits to verify compliance with procedures
Participate in and support of external regulatory audits and inspections
Attends and participates in departmental meetings.
Attends seminars and training sessions necessary to maintain.
appropriate level of professional competence.
Ensures all department compliance guidelines are met.
Attends all meetings in-services training or continuing education as delegated by the supervisor.
Provides customer focused interactions.
Performs all duties necessary for the department as per department policies and procedures.

Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.
Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care. React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace. We are an Equal-Opportunity Employer and do not discriminate against any employee or applicant for employment because of race color sex age national origin religion sexual orientation gender identity status as a veteran and basis of disability or any other federal state or local protected class.

POSITION:Senior Design Quality Engineer (Oxygen and Sleep)FULL-TIME/PART-TIME:Full TimeLOCATION: (Dublin OH)React Health is a fast-paced growth-driven manufacturer and distributor of medical equipment dedicated to supporting patients caregivers physicians and healthcare providers. With a focuson res...