Sr. System Engineer

Sr. System Engineer (Medical Device)

Essential Functions:

• Working knowledge of product development lifecycle, concept through launch

• Leads system/product-level feasibility and risks assessments

• Facilitates cross-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues

• Responsible for coordination of system-level product development and its integration

• Serves as a resource to examine system behavior issues and bring to resolution for on-market products

• Identifies opportunities and drives continuous improvement efforts

• Applies DFSS best practices on all projects.

Qualifications:

• Must have a bachelor’s degree in science or engineering. A post graduate degree is preferred.

• At least 5 years related work experience required (combination of work experience and advanced degrees).

Skills/Attributes:

• Ability to work independently and as a member of a team.

• Ability to lead multi-discipline engineering teams.

• A strong technical background within Systems Engineering, medical device development, or similar

• Experience with Systems Engineering and requirements management.

• Familiar with systems integration and testing, system architectural planning and design, Reliability Engineering, Project Management, and Failure Modes Effects Analysis.

• DFSS knowledge and experience or statistical test design and analysis knowledge or Critical Parameter Management.

• Excellent communication skills with the following departments: interdepartmental (with fellow engineers), cross-functional (with Marketing, Clinical Representatives, Software Engineers, Test Engineers, and Quality Engineers)

Nice to have:

• Good understanding of Basic Safety and EMC Standards e.g. 60601-1, 61010-1, 60601-1-2

• Good understanding of ISO 15223-1 and ISO 20417

• Quality Management System in SAP

• Team Foundation Server