MillenniumSoft Inc · 4 months ago
Senior Systems Engineer (R&D and Product Development) - Remote
MillenniumSoft Inc is a company specializing in medical devices, and they are seeking a Senior Systems Engineer to support product development and integration. The role involves translating customer needs into product requirements, leading technical projects, and driving continuous improvement within the Systems Engineering function.
Staffing & Recruiting
Responsibilities
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
A Senior Systems Engineer in this role is responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems Engineering support through various phases of product life cycle
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
Qualification
Required
Must have a Bachelor's degree in Science or Engineering
At least 5 years related work experience required (combination of work experience and advanced degrees)
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
Preferred
A post graduate degree is preferred
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