Senior Systems Engineer

Katalyst CRO; Plymouth (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Systems Engineer to drive end-to-end systems engineering for medical device products, from development through post-market surveillance.

You will work with electrical, software, and mechanical teams to translate user needs into compliant design solutions, utilizing SysML/UML and DOORS for requirements management in a regulated setting.

Qualifications

• Degree in an engineering or science discipline as listed in the job ad.
• Experience in medical devices, preferably ICU or kidney care.
• Solid systems engineering knowledge across electro-mechanical and software domains.
• Background with regulated products and design control processes.

Responsibilities

• Perform systems engineering across product lifecycle from development to post-market.
• Capture inputs from user needs, regulatory standards, quality and manufacturing.
• Drive design realization from a systems perspective and mitigate risks.
• Lead with SysML/UML modeling and requirement management.
• Ensure compliance with FDA, ISO, IEC design control procedures and standards.
• Collaborate with stakeholders across global, multi-functional teams.
• Deliver results according to project plans.

Skills

Analytical thinking

Problem solving

Communication

Independent work

Project management

Cross-functional collaboration

Education

Bachelor's or Master’s degree in Electrical, Software, Mechanical, Biomedical or related engineering/science

Tools

SysML/UML

DOORS

Jama

Teamcenter

TrackWise8

JIRA

ALM

Job description

Roles & 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

Education And Experience

• Bachelor's degree or Master's degree and three years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• 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 and Jama requirements management tools preferred
• Knowledge of 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