What are the responsibilities and job description for the System Engineer position at Kaygen, Inc.?
This Systems Engineer translates voice of customer and stakeholder needs into system and product requirements, identifies potential hazards, and assesses requirements to ensure that the product meets the user/business needs, develops design and process specifications for new hardware and software products, aids in product verification and validation, and provides support in sustaining activities. The expectation for a Senior Systems Engineer is that they regularly serve on smaller project core teams, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such they are expected to help identify tasks/resources to ensure that critical project milestones are met, and systems integration activities are identified and fulfilled.
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)
• Must have strong writing skills.
• Identified opportunities for continuous improvement projects/efforts.
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
