USA - Systems Engineer II
US Tech Solutions, Inc.
Milwaukee, United States of America
16 days ago
Role details
Contract type
Temporary contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
Intermediate Compensation
$ 123KJob location
Milwaukee, United States of America
Tech stack
Systems Engineering
JIRA
Pareto Chart
Software Tools
Software Engineering
Systems Integration
Teamcenter (Software)
Job description
- 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, 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 responsibilitie
Requirements
- 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
- Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred
- Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
- 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