Lead Systems Engineer
Role: Permanent
Location: Stryker Anngrove, our state of the art Additive Institute
Very flexible hybrid working model.
What you will do:
Technical Responsibilities:
• Independently 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
• Allocate and decompose requirements on a multi-disciplinary (electrical, mechanical, software) project using modeling, simulation, budgeting, or mathematical techniques
• Lead Concept Phase activities for a feature
• Analyze and correct complex product design issues using independent judgment
• Lead analytical studies, including trade studies, sensitivity studies, optimization studies, performance assessments, and design assessments
• Lead system integration testing and verification activities
• Contribute to Product Risk Management activities
Business Responsibilities:
• Advance solutions by applying in-depth knowledge of customer needs, market, and competitive offerings
• Apply detailed knowledge of clinical procedures to author design inputs
• Support Voice of Customer sessions internally and with clinicians
• Demonstrate developing financial acumen
Med Device Compliance:
• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
• Lead creation and refinement of engineering documentation, such as the Design History file
• Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System
General Responsibilities:
• Work cooperatively with all stakeholders to ensure project success
• Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology
• Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process
• Deliver high quality results with passion, energy, and drive to meet business priorities
• Collaborate with cross-functional teams to build partnership to achieve business objectives
Minimum Qualifications (Required):
• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 4+ years of work experience
Preferred Qualifications (Strongly desired):
Technical Skills:
• Strong technical ability to develop and optimize system requirements, designs, and verification
• Working knowledge of Requirements Management Tools and System Modeling Tools
• Ability to communicate moderate complexity 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
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Travel Percentage: 10%