Job description

Systems Engineer

Idea Evolver is looking for a detail-oriented Systems Engineer to help spearhead a Software as a Medical Device (SaMD) project for our client. Join a talented SaMD team working to build first-of-its-kind medical software. In this role, the Systems Engineer will be responsible for:

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Drive and directly contribute to Systems Engineering requirements management in line with internal quality procedures and external regulatory standards.

• Write clear, concise, non-ambiguous, non-conflicting, testable and traceable requirements.
• Leading requirement refinement process by understanding client requests and engaging cross-functional team members to further decompose high level requirements into software functional requirements.
• Providing technical guidance from a systems architecture and engineering perspective critical to improving the accuracy, stability, and overall performance of the SaMD application, while adhering to regulatory requirements.
• Lead the planning and definition of risk management and hazard analysis activities in compliance with FDA and international standards including ISO 14971.
• Identifying and resolving design issues that could impact product performance, user experience, business needs and priorities, and resourcing costs.
• Serving as a Subject Matter Expert for the product.
• Employing engineering principles to foresee technical and schedule risks and to implement appropriate mitigation approaches that minimize risk and maximize value.
• Overseeing innovative solutions to complex technical problems from ideation to execution.
• Finding developmental opportunities for the creation of building blocks that can be leveraged across future product enhancements or in the creation of additional products within the portfolio.
• Staying current with evolving trends and guidances in the security and performance of SaMD products.

Qualifications

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Bachelor’s Degree with at least 3-5 years of experience in a Systems Engineering capacity, preferably in the SaMD space.

• Knowledge of ISO 14971 and IEC 62304.
• Experience working on a variety of products
• Strategic thinker with strong verbal and written communication and presentation skills
• Effective planning, organization, analytical and leadership skills
• Proactive and analytical nature that sees challenges as opportunities
• Brings a can-do-attitude to work and inspires others to raise their performance bar, highly organized and brings quality orientation to everything they do.
• Comfortable working and thrives in a fast paced environment.
• Full software development life cycle experience with solid understanding of both the practices and principles of Scrum and Agile development and how can be applied to regulated work products.

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Job Type: Full-time

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