NEW JOB OPENING
SENIOR SYSTEMS ENGINEER
IN Plymouth, MN, USA!

Required Education/Experience:



• Bachelor's in Electrical, Software, Mechanical, Biomedical Engineering, or a related engineering/science discipline.



Required Qualifications:



• Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains.

• 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 cybersecurity.

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.



Required Technical Skills:



• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering.

• Working knowledge of system modeling language (SysML or UML) and requirement management tools.

• Knowledge of DOORS and Jama requirements management tools .

• Knowledge of Teamcenter, TrackWise8, JIRA, and ALM preferred.

• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size.

• Knowledge of FDA, ISO and IEC design control procedures, regulations and standards.



Responsibilities:



• 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.

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**