If you are enthusiastic about technology, passionate about quality, and have experience as a Software Quality Engineer with experience in medical device product development, please inquire.
This individual will work on cross-functional product development teams as a software quality engineer for the product and will be mostly responsible for product software verification activities. These include developing specifications, test protocols, test reports, and risk management activities.
Specific Responsibilities :
- Scoping and assessing the required verification effort during the development of a proposal that includes defining a verification process schedule and corresponding resource allocations.
- Developing, or assisting with the development of, software/firmware requirements, Software Verification Test Plans, Protocols and Reports.
- Developing design requirement trace matrices to system level requirements and to verification protocols.
- Developing hazard and risk analyses, including Fault Tree Analysis and Failure Modes and Effects Analysis for software (as needed), and recognizing software modes of control to mitigate potential risks.
- Developing test fixtures and software utility specifications as needed for engineering confidence testing, and for software verification. Validating such fixtures and utilities for intended use.
EOE. Compensation DOE.
- Working knowledge of FDA Quality System Regulation, 21 CFR, Part 820, Design Controls and medical safety standards such as IEC 62304, Software Life Cycle Processes, and ISO 14971, Application of Risk Management to Medical Devices.
- Experience developing software requirements and interface requirements, software verification test protocols, and verification summary reports.
- Experience developing hazard and risk analyses, including Fault Tree Analysis and Failure Modes and Effects Analysis.
- Experience testing embedded firmware and/or application software as it applies to medical devices (i.e. user interface applications, touch screen applications, etc), communications interfaces, etc.
- Familiarity with software/firmware coding practices, structures, testing methods, and requirements.
- Proven ability to work effectively on cross-functional teams.
- Bachelors Degree in Software or Electrical Engineering preferred.
- A minimum of 8 years experience with product development of medical devices, or equivalent, as a software quality engineer.