ABOUT THE COMPANY:
Inflammatix, Inc. is a venture-backed diagnostics company bringing the power of precision medicine to the point of care. We are building novel diagnostic, prognostic, and predictive HostDx™ tests that combine rapid detection of host mRNA panels with advanced machine learning and computational biology. These tests will be performed on our rapid point-of-care platform instrument currently under development, intended for both US FDA and CE Mark clearance. Our products, the HostDx-Sepsis and HostDx-Fever systems focus on enabling physicians to better diagnose acute infections and sepsis. Inflammatix is further developing a pipeline of groundbreaking tests that take advantage of our expertise in reading the immune system.
JOB DESCRIPTION: Systems Engineer
JOB LOCATION: Los Gatos, CA
Our Systems Engineer will ensure proper translation of user, caregiver, and a variety of additional stakeholders’ needs into clearly defined, verifiable design inputs. They will collaborate with project teams to define system solutions, architectures (design outputs) and interface requirements between various subsystems to adequately meet the design inputs.
Additional activities include determining the essential requirements necessary to drive initial concept development, leading systems architecture concept development sessions, and creating rating criteria for concept ranking, prioritizing the development strategy, and acceptance of early architectural concepts. Act as the hub of the product development team by engaging all engineering disciplines (including but not limited to Mechanical Engineering, Electrical Engineering, and Software Engineering architects) to organize system architectures and product development activities. Parallel activities will include translating the early research findings and regulatory requirements into functional requirements with documented rationales, intended to be measurable and verifiable or validated at later stages. Late-stage activities include advising on formal verification plans in collaboration with Design Assurance Engineers for risk assessments and assisting with test method development. The role will also require the incorporation of directly related standards and regulatory requirements.
- Lead systems engineering efforts and drive related deliverables on multiple projects
- Develop design input requirements, exercise analysis tools such as parsing, and ensure rationales are provided for requirements
- Ensure compliance with appropriate regulatory standards for the product
- Collaborate with user research specialists to gather and prioritize stakeholder needs
- Work with product management and commercial teams to gather and prioritize business needs and pre-defined design constraints
- Define essential requirements necessary to drive very early concept development
- Lead systems architecture concept development sessions; create rating criteria for concept ranking and acceptance of early architectural concepts
- Translate early research findings and regulatory requirements into functional requirements.
- Capture the evolution and ultimate systems design output, rationales, and lower-level requirements associated with a final design
- Contribute to formal verification planning in collaboration with assigned Design Assurance Engineers, and assist with test method identification and development
- Keep abreast of related laws and regulations, and incorporate compliance within systems engineering deliverables
- Participate in continuous improvement efforts related to systems engineering processes
- Lead test planning and execution for subassemblies and prototypes
- Lead technical troubleshooting efforts
- Coordinate with and guide external partners across a variety of technical competencies
- Assess and test technologies and components for incorporation into our POC platform
An individual holding a bachelor’s degree in a related field, coupled with 2-5 years of experience within the product development industry. Familiarity with related standards and medical device development is a plus. Experience with typical industry requirement management systems is a plus. Our fast-paced environment demands the ability to manage multiple projects within the discipline 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