Description:

Summary
In the Systems Engineer role, you will be supporting the overall technical direction of Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. Tasks may include product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

What you'll be doing:
Perform the activities associated with the systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance
Understand clinical and user needs and apply them to product realization
Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.
Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective
Craft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area
Create and maintain design history file elements
Facilitate an improved understanding of the interrelationship between requirements, risk and reliability
Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results
Resolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.
Propose and drive solutions to technical problems that are ambiguous and diverse in scope
Perform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. As needed, propose recommended mitigations with rationale.
Influence stakeholders and cross-functional team members within the project
Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
Use various software tools and programs to complete the above responsibilities

What you'll bring:
Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains
Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
A track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military
Prior experience with internet-connected, software-enabled devices and/or cyber security
Working knowledge of system modeling language (SysML or UML) and requirement management tools
Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred
Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
Success in working with multi-functional, global teams
Excellent interpersonal, communication, and influencing skills
Ability to work independently
Ability to manage simultaneously several projects and shift priority according to needs
Demonstrated strong analytical and problem-solving skills
Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders
Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
Ability to deliver results according to the plan

Experience and/or Background:
Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
Three or more years of relevant experience