Senior Medical Systems Engineer for Regulated Devices

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

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.