Honorable purpose serving patients and pets: Join Midmark's Digital Ecosystem Team, where we improve the lives of patients, human and furry, in the areas of medical, dental, and animal health.
We're looking for a talented Quality Systems Engineer to join our cloud-solution develop team. You will provide technical expertise and leadership for software engineering, IT, and architecture teams in support of product and process development activities. You'll play an active role in the design and implementation of quality practices and tools for software development and systems integration. This position comes with an annual bonus, continuous training opportunities, flexible work hours, and an amazing team culture.
This position is located at either of our Miamisburg, OH or Versailles, OH offices with a preference for candidates located in the Cincinnati, Dayton, and west central Ohio areas.
* Analyze and evaluate existing tools and methods used in the development of on-premise and cloud-based software for customer-focused and business applications
* Responsible for working with Agile software engineering teams to establish processes and methods for requirements management, testing, traceability, and system design within an IT (GxP) quality management system (QMS)
* Ensure compliance with, and improve, QMS policies and procedures
* Work with software teams to specify, acquire, and implement tools to improve the efficiency of software development and the quality of software deliverables
* Work with product managers, process owners, and end-users to understand their needs, use-cases, operating environments, and processes
* Partner with product managers, product owners, and stakeholders to refine features, stories, performance and security requirements for software and data storage systems, applications, and processes
* Support system-level verification and validation planning and execution activities ensuring customer and regulatory requirements are satisfied
* Proactively support and promote Engineering Excellence initiatives, including systems engineering best practices, Six Sigma, FMEA, design guidelines, etc.
* Maintain awareness of trends, best practices, and emerging guidance for software development and systems integration and act as a subject matter expert in these areas
* Keep senior management apprised of personnel, project, and external issues that interfere with the team's productivity or the ability to produce quality products
* Maintain awareness of FDA, regulatory, and QMS requirements and Midmark policies and procedures that affect projects and provide input on deficiencies with regard to these standards
* Mentor junior-level engineers, analysts, and technicians within the IT and engineering teams
* Establish and maintain effective communications throughout IT and engineering departments
* Interact collaboratively with a wide range of disciplines
* Take an active role in supporting and responding to IT audits
* Create technical budgets, allocate resources, and determine the schedule for software releases and project deadlines
* Participate in design reviews
* Develop and maintain relationships with key suppliers and other partners
* Provide work estimates based on analysis of effort needed to satisfy requirements
EDUCATION and/or EXPERIENCE:
Bachelor's degree in relevant IT or engineering discipline (e.g., Computer Science, Information Systems, Electrical, Biomedical, or Systems) and 5 + years of experience, or equivalent combination of education and experience. Systems Engineering degree or certification, preferred. Master of Science in an IT or engineering discipline or M.B.A, preferred.
* Strong planning, organizational, and project management skills
* Strong communications skills (verbal and written)
* Strong ability to work in a team environment while possessing the ability to remain focused when working alone on a project
* Strong analytical skills to investigate problems and develop solutions
* Ability to work under pressure and meet deadlines
* Comfortable working in a fast-paced and dynamic technical environment
* Experience in quality system development or continuous improvement initiatives, Agile software development, and process requirement development.
* Experience in a healthcare, medical devices, or clinical setting, preferred
- Agile Methodology
- Biomedical Engineering
- Business Process Improvement