Principal Systems Engineer

• Lead development of Design Inputs and Digital Interface Requirements
• Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements
• Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements
• Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market
• Resolves interface issues and have the ability to document theory of operations of complex medical product designs
• Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods
• Support risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation in support of the Safety Assurance Case
• Implement configuration management through the complete product life cycle, including design, development, and sustaining phases
• Interface with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process
• Ensure compliance to the product development process and Quality System

• Bachelor’s degree required with 5+ years of experience or Masters with 3+ years of experience
• Solid understanding of systems engineering principals and related disciplines, Electro/Mechanical, Digital Interface, Fluid Mechanics, Materials Science, etc.
• Success in delivering results on technical challenges including investigative and problem-solving skills (DFSS/DMAIC/CAPA)
• Prior medical device preferred, Infusion Pumps and Syringe Pumps is a plus
• Good communication skills, both oral and written
• Applicants must be authorized to work for any employer in the U.S.

Prior medical device preferred, Infusion Pumps and Syringe Pumps is a plus

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits