Senior Systems Engineer

Job Summary:

The Systems Engineering function is responsible for medical device development projects including working with a cross-functional team on tasks such as: project planning, defining requirements, traceability assurance, testing, problem debugging, risk management, and schedule compliance. Position will work with varied stakeholders modeling performance aspects of the system and defining various interfaces between sub-systems and environments. The Senior Systems Engineer is multidisciplinary but possesses a depth of knowledge in one or more focused engineering areas.

Duties and Responsibilities include, but are not limited to:

• Owns or supports development of system engineering project plans; provides feedback on development strategy, development cost, product cost, project risks (technical, schedule or deliverable), and timelines for each project
• Owns or supports deliverables for the Systems Engineering activities such as; architecting, planning, analyzing, design, integration and test.
• Prepare technical reports including System Design, Design of Experiments (DOE), external interfaces, internal interfaces, component qualification, product testing, FMEA, statistical analysis
• Coordinates and is accountable for Human Factors activities and deliverables
• Participate in all phases of development across multiple projects; investigate interchangeability, replacement, cost factors, and ease of manufacture. Coordinate with project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs, applicable standards, and procedures. Work with all Project team members throughout the development in order to ensure that products are produced in a safe, efficacious and quality manner while keeping within established timeframes
• Communicate project information both within and external to the company

Knowledge, Skills, and Abilities:

• Candidate must have strong analytical skills to analyze dependencies in a project, and be able to proactively understand/anticipate the critical paths on projects
• Ability to lead engineering projects and work autonomously
• Familiarity with product development processes in a highly regulated industry
• Applies and champions Systems Engineering best practices
• Experienced with common engineering tools
• BS degree is required, and graduate degree (MS or PhD) is preferred (EE, BME, CS, CE)
• 5+ years’ experience in design/development of multi-domain (EE,BME) systems; particularly desirable is medical device development experience with BS, or 3+ years’ experience with MS/PhD
• Other minimal travel requirements