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Job #:  536
Job Title:  Principal Systems Engineer
Perm or Contract:  Permanent
Date Posted:  05-Mar-2020
Location:  Santa Rosa, CA
Area Code:  707
Skills:  Systems architecture design, medical device industry; cardiovascular experience preferred
Job Description:  This is an exciting opportunity to join our Structural Heart business unit to work with a dedicated team focused on the development and expansion of our new transcatheter mitral valve replacement system. In this role, the Principal Systems Engineer will develop system architecture, identify and manage interfaces, and manage requirements flow across the implant, catheter, accessories and packaging.

A Day in the Life
Implement general design, engineering, and scientific principles to drive the development of products
Apply advanced problem solving skills, critical thinking, technical principles, and theories to solve complex problems
Design a systems architecture that aligns the needs of the business and the customer
Lead the collection, analysis, and modeling of user needs, business needs and use cases and transform them into high quality stakeholder and system requirements
Lead the analysis of identified design solutions to ensure fulfillment of needs, use cases and requirements
Generate and approve requirements and specifications for all aspects of product concept; ensure that all systems are developed in harmony and support each other
Provide expertise and leadership in planning and conducting user evaluations of product concepts
Manage product interfaces across implant, catheter, accessories and packaging, including setting up requirements flow and ensuring design changes are properly evaluated
Provide expertise and leadership in identifying and addressing technical risks, product hazards and failure analysis
Develop a program risk burn down strategy and guide team in decisions requiring key design tradeoffs
Lead multiple system engineering activities in the product development life cycle including identification, planning, monitoring and executing tasks for entire project
Lead cross-functional teams to make appropriate, timely decisions and recommendations that result in the successful completion of major organizational objectives.
Provide mentorship and coaching to engineers and product development teams
Establish and advocate for best practices and continuous improvement to mature systems engineering knowledge and processes
Develop solid understanding of targeted therapies and clinical applications
Lead, coordinate, execute, and document system analysis and design activities
Provide technical review on current product development activities
Identify and lead collaborations with internal and external engineering groups

Responsibilities may include the following and other duties may be assigned:
Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems
Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal
Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints
Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications

Must Have: Minimum Requirements
Minimum of 7 years of experience, or advanced degree with a minimum of 5 years experience

Nice to Have
Experience with CodeBeamer
Expertise in the medical device industry; cardiovascular experience preferred
High level proficiency of technical principles, theories, and design concepts in the field of medical device design
Expertise in catheter design
Proven leadership in implementing systems engineering tools and practices in the development of new products
Project management skills including leading a complex project team as well as planning and estimation of tasks, milestones, resources and budget
Knowledge of statistical analysis software and applications
Excellent communication skills (written and verbal)
Ability to work well in a team
Self-starter and driver able to execute effectively and work efficiently
Job #:  536

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