Title: Systems Engineer

Pay Rate: $60.00/hr

Location: Remote - CST or PST

10% Domestic Travel

Note: This is a W2 contract role, and it is NOT open to C2C or 3rd party candidates

Manager Requirements:

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

This is on the hardware side concerned with safety strong 660-1 0r -2

Summary:

The Systems Engineer translates the voice of customer and stakeholder needs into system and product requirements, identifying potential hazards and assessing requirements to ensure that the product meets user/business needs. The Systems Engineer will develop design and process specifications for new hardware and software products, aid in product verification and validation processes, and provide support in sustaining activities. The expectation for this Systems Engineer position is that they will regularly serve on smaller project core teams, acting as a leader of technical excellence and participating 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. Systems Engineers in this role are responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems Engineering support through various phases of product lifecycles.

Position Duties:

1. Leading system/product-level feasibility and risks assessments
2. Facilitating cross-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues
3. Coordinating system-level product development and its integration
4. Serving as a resource to examine system behavior issues and bring to resolution for on-market products
5. Identifying opportunities and driving continuous improvement efforts
6. Applying DFSS best practices on all projects

Position Qualifications:

1. 5+ years of Systems Engineering work experience, including experience with requirements management
2. Familiarity with systems integration and testing system architectural plans and designs
3. Experience with Reliability Engineering Project Management and Failure Modes Effects Analysis
4. Knowledge of DFSS and experience with statistical test design or analysis
5. Working knowledge of product development lifecycle concepts through launch
6. Ability to identify opportunities for continuous improvement
7. Ability to work independently and as a member of a team, including leading multi-discipline engineering teams
8. Excellent communication skills, with the ability to interact with fellow engineers and cross-functionally with marketing, clinical representatives, software engineers, test engineers, and quality engineers
9. Strong writing skills
10. Technical background within medical device development or similar field preferred
11. Knowledge of Critical Parameter Management preferred
12. Understanding of Basic Safety and EMC Standards, e.g. 60601-1, 61010-1, or 60601-1-2 preferred
13. Understanding of ISO 15223-1 and ISO 20417 standards preferred
14. Experience with a Quality Management System in SAP preferred
15. Experience with Team Foundation Server preferred
16. A minimum of a Bachelor’s Degree in Computer Science, Engineering, or other related field required; Master’s Degree in a related field preferred

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