This role will be fully remote and can start ASAP!
This position requires knowledge and experience in driving Systems Engineering on multiple engineering projects in the medical device and software as a medical device field. This Principal position requires direct customer interface and leadership skills to manage a project and build alignment with the client. It requires the ability to delegate tasks and direct others based on client needs. This position requires in-depth knowledge and demonstrated experience with system engineering skills. The successful candidate will be a self-starter with strong work ethic and initiative in accomplishing objectives.
Requirements Development proficiency in traditional system engineering practices including requirements elicitation from the clients around the end users of medical devices. The ability and skill of requirements elaboration which takes the user needs and translates them into system and software design requirements
Requirements Management proficient and practiced in developing and implementing requirement structure schema and hierarchy using requirement management tools, proficient in requirement allocation and the ability to correctly trace and develop requirement trace matrices
Safety Risk Analysis Proficient with planning risk analysis for complex medical devices (that contain software), understand and identify potential harms and hazards leading to harm, ability to perform bottom-up failure analysis (FMEA)
Compliance Engineering Familiar with key Standards/FDA guidance for medical devices that contain software that impact the development process and impact the product design. Standards such as IEC60601-1, IEC62304, ISO14971, IEC62366, IEC60601-1-8 and FDA regulation 21 CFR part 820, FDA guidance including GPSV, design control guidance and the software submission guidance
V&V Leadership proficient in V&V strategy, V&V planning software V&V approaches. Methodology in test development which includes test planning, design, and test case creation
Testing proficiency Including unit, system, and GUI testing
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.