We are seeking a Systems Engineer with full cycle product development experience taking medical device product(s) to market. You will work closely with our development teams to design, define, manage and document laboratory developed tests for cancer diagnostics throughout the development lifecycle, as well as support FDA submissions within an IVD framework. The Systems Engineer documents user requirements, develops system requirements, participates in product architecture and design, drives risk analysis, and usability engineering and supports integration and testing activities for both on-market products as well as new product introduction. In this role, you’ll have the opportunity to collaborate with functional leaders in software, hardware, assay development, research, quality, commercial and manufacturing. As well, the Systems Engineer may have interactions with customers, clinicians, third-party vendors, manufacturers, and others.
ESSENTIAL JOB FUNCTIONS
Works with product management and marketing early in the development cycle to define & scope
customer needs and required functionality.
Develops the system requirements documentation. Participates in system architecture & integration design, development, testing documentation and implementation to decompose the System Requirements Documentation into a structured hierarchy of progressively smaller, but cohesive sub-systems and well-defined interfaces. Creates subsystem requirements documentation.
Documents all aspects of system design and development in accordance with design control requirements.
Conducts and documents hazard and risk analysis for projects
Supports design activities as needed, and attends design control reviews
Develops and maintains requirement traceability through various subsystems and verification activities in collaboration with subsystem requirements owners
Drives system integration, optimization, and root cause analysis with the development teams during system integration, Alpha testing, and device pre-Beta testing
Establishes and maintains alignment across departmental disciplines with focus on execution, continuous improvement, and operational excellence.
·Works with the testing team to develop strategies for system level product integration and testing; including software, electrical, analytic, and mechanical aspects of the system
Leads and drives system risk management activities for system and subsystems throughout the development lifecycle.
Supports other teams as needed to ensure a structured approach to product validation
Contributes to data-driven decision making by designing experiments and collecting, analyzing, and presenting data results.
Other duties as assigned
Bachelor’s degree in Software engineering or Electrical Engineering preferred but open to Computer Engineering Mechanical Engineering, Biomedical or related Engineering discipline
5+ years industry experience in a consumer goods, medical device, biotech or other regulated industry in the following:
o Experience involving software and hardware implementations for in vitro diagnostics or medical devices under design control (21 CFR Part 820, ISO 13485) in a regulated environment
o Experience with understanding and generating deliverables related to design controls in support of a regulated industry
o Experience writing clear and concise requirements and documentation.
o Experience delivering a product to market
o Embedded systems experience preferred
o Experience applying DOE to systems under development (preferred)
o Experience with UML (preferred)
Proficiency in Microsoft Office Suite/Google Suite
Excellent verbal and written communication skills.
Self-starting attitude and aptitude
Ability to work with functional system owners to design and develop future proof, scalable and integrated systems from beginning to end of the workflow(s).
Ability to work independently and collaboratively in a fast-paced environment and able to adapt to change
·Ability to influence and work through others to achieve results cross-functionally.