Senior Systems Engineer

VIVA USA Inc; Plymouth (MN); On-site; USD 90,000 - 130,000; Part time

Job summary

VIVA USA Inc is seeking a System Engineer (contract) to guide the technical direction of Acute Therapies products. You will drive product development from feasibility through lifecycle management, shaping design concepts, requirements, and risk strategies.

Responsibilities include systems integration, design history file maintenance, and ensuring FDA/ISO/IEC design controls are followed. A strong background in electro-mechanical and software engineering is required, with cross-functional

Qualifications

• Bachelor’s or Master’s degree with 3+ years of relevant experience in engineering or science.
• Experience with medical devices preferred, ICU/kidney care domains a plus.
• Strong systems engineering knowledge including electro-mechanical and software aspects.

Responsibilities

• Conduct systems engineering activities across product lifecycle, from development to post-market surveillance.
• Translate clinical/user needs into product requirements and design concepts.
• Capture requirements from sources like regulatory standards, human factors, quality, and manufacturing.
• Manage design history files and support risk management, verification, and validation.

Skills

System thinking

Analytical thinking

Problem solving

Independent work

Cross-functional collaboration

Regulatory awareness

Communication skills

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

DOE (design of experiments)

Job description

Client is seeking a System Engineer (contract) to support 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 development of design concepts/changes, 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:

• 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

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status