Address
Form of work
SalaryFULL-TIME/PART-TIME: Full Time
POSITION: Senior Design Quality Engineer
LOCATION: Hybrid
POSITION: Senior Design Quality Engineer
LOCATION: Hybrid
React Health is a fast paced, growth oriented, manufacturer and distributor of medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers. React Health sells and supports its product and services in the acute-care, non-acute and home medical equipment markets. React Health has built a model that combines manufacturing and distribution of products and services to meet the challenges of the undiagnosed as well as those needing therapies after diagnosis in the sleep and respiratory population.
GENERAL SUMMARY
The Senior Design Quality Engineer will work directly with the Design teams to support new product development and sustaining of React Health's sleep therapy devices, ensuring risk management of new 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 ISO14971, 21CFR820, 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 test method development and the validation of those test methods
- Experience with risk management file creation and updates
- Bachelor’s degree in engineering, life sciences or related field
Preferred Education
- Master’s 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
- EUMDR (European Medical Device Regulation)
- Design for Six Sigma
- House of Quality
- 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.
ABOUT THE ORGANIZATION React Health is committed to providing innovative sleep, sanitation and consumer devices. Our goal is to provide the highest quality products that comply with all regulatory requirements and meet or exceed the market expectations and needs of our customers, employees and investors.
BONUS: Potential bonus based on performance / Signing bonus
