This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
As a Principal Systems Engineer you will support the development activities for complex medical devices that meet customer needs and regulatory standards. This role works with talented systems, hardware and software engineers in resolving difficult problems by applying standard system engineering principles, methods, and techniques (Requirements and Risk Management, Issue Management, Configuration Management) to ensure our products meet medical device design control best practices.
Job Responsibility
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
Requirements
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
Nice to have
Prior medical device preferred
Infusion Pumps and Syringe Pumps is a plus
What we offer
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
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
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