Senior Systems Engineer

Creative Solutions Services, LLC; Plymouth (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Systems Engineer to drive the end-to-end systems approach for medical device products. You will translate clinical needs into robust requirements and guide design from concept through post-market activities.

Responsibilities include risk management, design control, and collaboration with cross-functional teams. A strong background in regulated medical devices and SysML/UML skills is required.

Qualifications

• Bachelor's or Master’s in an engineering or science field, with 3+ years in medical devices.
• Experience with electro-mechanical and software engineering in regulated products.
• Familiarity with system modeling and requirements management tools.

Responsibilities

• Perform systems engineering across product lifecycle from development to post-market.
• Translate clinical and user needs into product realization and requirements.
• Capture inputs for requirements from sources like regulatory standards and quality.
• Apply technology, process, and therapy knowledge to drive design from a systems view.
• Craft design concepts and research methods meeting current and future needs.
• Create and maintain design history file elements.
• Explain relationships between requirements, risk and reliability.
• Lead mitigation strategies for technical challenges and risk scenarios.
• Resolve systems-related issues using root-c cause analyses and Pareto charts.
• Propose solutions to ambiguous, diverse technical problems.
• Conduct impact assessments for design/material/process changes with mitigations.
• Influence stakeholders and cross-functional teams within projects.
• Ensure adherence to FDA, ISO and IEC design controls and standards.
• Utilize software tools to complete responsibilities.

Skills

Systems engineering

Medical devices

Problem solving

Regulatory awareness

Requirements management

Cross-functional collaboration

Analytical thinking

Independent work

Project prioritization

Communication skills

Education

Bachelor's or Master's in Electrical, Software, Mechanical, Biomedical or related field

3+ years of relevant experience in medical devices or regulated products

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