This role supports the development and sustaining of commercialized software products within the medical device sector. Responsibilities include managing design risk, conducting failure investigations, and coordinating with cross-functional teams to define system specifications.
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 focus on 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
This role, the Senior Software Design Quality Engineer provides support for development and sustaining of commercialized software product.
QUALIFICATIONS
7+ years of experience or equivalent experience in Medical Device Design control for software product and the application of ISO14971, 21CFR820, 21CFR11, MDDS, ISO13485, IEC62304, IEC62366, IEC60601, IEC60812, and IEC 82304
Experience with development, validation and design changes of software products.
Experience with risk management file creation and updates w.r.t. software products
Ability to navigate the regulatory aspect of the software development for products that are web based, multi-tenant, high transaction compliance platform for reusable equipment data transfer.
Experience with patient facing Mobile apps to support the above platform which may be Class 2 or MDDS.
Create, contribute to the creation of, and/or review project plans, quality plans, validation/verification plans, software development plans, and /or software maintenance plans.
Create, contribute to the creation of, and/or review product requirements and software requirements.
Preferred Education
Computer Science or Electrical engineering degreed.
Preferred Experience
DHF (Design History File) remediation when moving from one design control system to another
EUMDR (European Medical Device Regulation)
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:
Ability to review and approve changes to currently commercialized product w.r.t. the design risk management of the product.
Applies statistics to make business decisions.
Ability to conduct failure investigation and root cause analysis.
Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.
Coordinate and work closely with other engineering, logistics, financial, and program management disciplines to define system specifications and requirements.
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.
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