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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