We are seeking an Embedded Software Design Engineer to fill a critical role in our organization. Seeking candidates wanting to grow their career in Software Design while supporting ISOPURE’s goal of producing high quality Medical Devices and Water Treatment systems.
ABOUT US
ISOPURE Corporation’s water treatment systems are based on thirty years of design with a focus on flawless integration of today’s technology into every piece of equipment that we build.
We began with the reception of our first FDA 510(k) clearance in 1986. This 510(k) clearance was for an innovative primary water purification device, which is still in production today. Since the release of our patented on-board cleaning technology, first introduced in 1986, the three-step chemical process has proven over the years to be the best technology to clean and disinfect any compatible primary purification system. With future growth based around these accomplishments, we have received multiple 510(k) clearances enabling ISOPURE’s initial focus to be strictly based in the medical water treatment sector. Throughout the past two decades of medical water treatment development, we also have used similar technology to generate an industrial water treatment portion of ISOPURE Corporation.
POSITION SUMMARY:
In this role, you will receive two weeks of (paid) training, in which you will gain an understanding of ISOPURE’s key product lines with hands on training in our testing and qualification department as well as intro training into our FDA documentation and other GMP training. Once your working knowledge goals of the product lines and portions of ISOPURE’s document control systems have been met, you will move towards a goal of ultimately working along side other engineers to design, develop, and audit current software. You will work in an accelerated learning capacity to aid with design updates for current designs and begin new projects from scratch along side the development team. While this position requires considerable independence to monitor and complete tasks as they are needed, you will receive on-going support and supervision from the engineering team and will have numerous available avenues to escalate scenarios and get information from anyone across the company.
RESPONSIBILITIES:
- Determines operational feasibility by evaluating analysis, problem definition, requirements, solution development, and proposed solutions.
- Documents and demonstrates solutions by developing documentation, flowcharts, layouts, diagrams, charts, code comments and clear code.
- Prepares and installs solutions by determining and designing system specifications, standards, and programming.
- Improves operations by conducting systems analysis; recommending changes in policies and procedures.
- Updates job knowledge by studying state-of-the-art development tools, programming techniques, and computing equipment; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Protects operations by keeping information confidential.
- Provides information by collecting, analyzing, and summarizing development and service issues.
- Accomplishes engineering and organization mission by completing related results as needed.
- Develops software solutions by studying information needs; conferring with users; studying systems flow, data usage, and work processes; investigating problem areas.
- Performs functions to establish feasibility of concepts and determines specific design inputs.
- Develops and designs software to an established design input requirement.
- Provide support and expertise in risk analysis, reliability, schematics/specification and analytical problem solving techniques.
- Provide proper documentation for their design tasks to support the FDA Quality System.
- Requirements and other regulatory bodies as well as customer requirements.
- Performs software testing, design Verifications and Validations as required.
- Create source code and compiled code packages.
- Support regulatory testing.
- Ability to design with Python, embedded C, Linux, Kivy, VSCode, and related software design tools.
- Familiarity with GIT, SVN, or similar version control systems.
- Performs other related duties as assigned.
POSITION REQUIREMENTS:
- Prefer a minimum of two years related work experience.
- FDA Quality System Regulation and design control experience preferred.
- Reports to and updates management on progress toward milestones.
- 4-year technical degree is preferred.
ADDITIONAL INFORMATION:
This position will require pre-employment background check and drug testing.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- Embedded software: 1 year (Required)
Work Location: In person