Principal Systems Engineer

Responsibilities

• 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 and 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
• 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 responsibilities
• Teach and mentor others in life cycle management methodologies

Requirements

• Bachelor’s degree and 5+ years or more of relevant experience, or Master’s degree and 4+ years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Prior experience in medical devices, preferably for ICU or kidney care domains
• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• Prior experience with internet-connected, software-enabled devices and/or cyber security
• Working knowledge of system modeling language (SysML or UML) and requirement management tools
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders
• Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
• Ability to deliver results according to the plan

Qualifications

• Advanced Molding and Extrusion techniques (Learning / Doing (1))
• Automation, reliability & smart manufacturing (Applying / Overseeing (2))
• Critical Systems (Applying / Overseeing (2))
• Data Analysis & Analytics (Applying / Overseeing (2))
• Digitalization & Systems Engineering (Applying / Overseeing (2))
• First Principles Thinking (Applying / Overseeing (2))
• Instrumentation (Leading / Driving (4))
• Lean & six sigma process knowledge (Applying / Overseeing (2))
• Machine Learning & Artificial Intelligence (Not Applicable (0))
• Manufacturing & Process Knowledge (Applying / Overseeing (2))
• Manufacturing Process Knowledge (Leading / Driving (4))
• Modeling & Simulation (Leading / Driving (4))
• Operational Quality Assurance (Applying / Overseeing (2))
• Process Automation (Applying / Overseeing (2))
• Product / Project Management (Applying / Overseeing (2))
• Product Knowledge (Leading / Driving (4))
• Quality Management Systems (Leading / Driving (4))
• Regulatory Compliance (Leading / Driving (4))
• Smart Operations / Industry 4.0 (Learning / Doing (1))
• Software Integration (API, Data Pipelines) (Not Applicable (0))
• Software Process Management (Leading / Driving (4))
• Sterilization methods (Leading / Driving (4))
• Systems Validation (Leading / Driving (4))