Ximedica is an ISO 13485:2003 certified and FDA registered full-service product development firm with offices in Providence, St. Paul, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
We have a close-knit, high-energy culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. This position supports our rapidly growing domestic and international product development, sourcing, and manufacturing business.
The Software Quality Engineer provides input to our development teams in the design of highly complex medical devices. They ensure that compliance to customer and regulatory requirements is demonstrated. They are responsible for accurate, independent evaluation of Design History File software documentation and overall Quality System compliance.
Nature of Role:
Reporting to the Software Engineering Manager, this resource performs software quality assurance engineering work that requires full competency in all conventional aspects of software engineering including embedded systems software, debuggers/emulators, Windows, Linux, real-time operating systems, continuous integration, manual and automated testing, requirements management and issue tracking.
A Bachelor’s degree in Computer Science/Engineering or equivalent education, coupled with 5-10 years of experience in embedded systems development within the medical device arena and the following key attributes:
- Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines on highly visible projects.
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers
- Must be able to travel occasionally to meet with customers / project teams
- Thorough understanding of requirements for design development, validation, and verification of medical devices.
- Experience with ISO 13485, IEC 62304, FDA design controls or similar regulatory environment.
- ASQ SQE preferred
Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:
- Successful communication skills, business acumen and assertive decision-making ability
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency
- Works closely with product development engineering and the client team to establish the software requirements specifications and product requirements.
- Participates with the engineering team to establish and review the software risk management activities, including design FMEA/Software Hazards Analysis practices.
- Initiates and maintains FDA software design control documents.
- Interfaces with design team to support functional test and measurement requirements.
- Works closely with design, development, quality, regulatory, and the client team to establish and document the software validation and verification plan in conformance with the system design specification and sound testing principles.
- Documents and performs integration, testing, and debugging support activities in cooperation with the engineering team.
- Documents and performs requirements verification activities.
- Works with the software engineering team to create a continuous integration solution for each project, to organize, track and test software builds for test and release.
- Maintains issue database, working with engineers to prioritize resolution of issues, reports on issue status and creates release notes for periodic software releases.
- Participates with cross-functional program teams in the creation of innovative product solutions and human interfaces by utilizing best practices of medical design, including usability design and engineering.
- Human factors engineering functions for computer human interface analysis, situational awareness, and human-in-the-loop scenarios is desirable.