Senior UX Designer
Who we want:
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
What you will do:
Technical Responsibilities:
Under minimal supervision:
• Research, design, develop, modify, and verify medical device systems
• Translate user needs to system requirements
• Modify existing system architectures or test designs
• Create new system architectures or test designs for simple product or features
• Contribute to design decomposition using, modeling, simulation, budgeting, or mathematical techniques
• Develop and analyze solutions, participating in Concept Phase activities
• Apply fundamental and some advanced concepts, practices and procedures for problem solving
• Execute analytical study protocols, including trade studies, sensitivity studies, optimization studies, performance assessments, and design assessments
• Participate in system integration testing
• Create and execute verification tests
• Contribute to Product Risk Management activities
Business Responsibilities:
• Demonstrate advanced understanding of customer needs and design inputs
• Demonstrate proficiency with product’s intended use and clinical procedures
• Learn how the financial models are constructed
Med Device Compliance:
• Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements
• Independently create or refine engineering documentation, such as the Design History file
• Follow R&D procedure like design controls and risk management, per the Quality Management System
General Responsibilities:
• Under minimal supervision, work with all stakeholders to ensure project success
• Quickly process and assimilate procedures, policies, processes, systems, and technology required
• Work on complex problems, applying advanced experience and learnings
• Demonstrate ownership and prioritize work with minimal supervision
• Works as key member of the team, collaborating with others and solidifying relationships
Minimum Qualifications (Required):
• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 6+ years of work experience
Preferred Qualifications (Strongly desired):
Technical Skills:
• Working knowledge and understanding of requirement and verification practices
• Working knowledge of Requirements Management Tools
• Ability to communicate basic plans and technical information to team members
Preferred Skills / Engineering tools:
• Requirements Management Software, especially Jama
• Experience with SysML and Model-based Systems Engineering
• Experience with SysML / MBSE software tools
• Knowledge of ISO 13485 and ISO 14971
