7 days old

Systems Engineer

Kelly Services
Cary, NC 27512
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

**Title:** Systems Engineer

**Location:** Remote

**Duration:** 12 months


+ Responsible for coordination and management of system design for one or more groups of related products to achieve defined program goals. This includes work related to the development of new products, and maintenance and engineering support of existing products.

+ Interfaces with other departments including Marketing, Sales, Service, Operations, Quality Assurance and Regulatory Affairs to define product requirements, communicate important information, and address issues relative to each product.


+ Work with Engineering Project Management to define and scope projects to achieve program goals.

+ Work with Upstream Marketing to understand and translate market needs into technical product requirements.

+ As a leader of the technical team, ensure technical product requirements are communicated and understood by the technical staff. Owner of the Design History File (DHF).

+ Ensuring technical product requirements are clearly and thoroughly documented. This includes the following:

+ Creation of system level specifications.

+ Ensures usability requirements are adequately addressed per IEC 62366.

+ Lead technical resource for Risk Management per IEC 14971.

+ Coordination and review of design level requirements to ensure they meet the system requirements and market needs.

+ Coordination and review of system and design level requirements to ensure they adequately consider serviceability and manufacturability of the product.

+ Responsible for DHF traceability by ensuring all requirements have been verified and validated. This includes creation of Verification and Validation Plans to scope the extent of testing required to maintain adequate traceability is maintained during a development project. This also includes completion of all documentation required to ensure compliance to standards.

+ Ensures requirements shared by similar products and their implementations are harmonized across those products, where possible.

+ Work with technical writing to ensure user documentation is sufficient.

+ Ensure end product configurations (MIS-14s, etc.) are created and updated as necessary to meet the market needs.

+ Leader of the Program Support Team.

**Other Responsibilities**

+ Manages periodic Program Support Team meetings.

+ Primary point of contact for Technical Support escalations.

+ Assist with complaint investigations as needed. Participate in CAPA activities as needed.

+ Management of Post Market Record investigations. Resource for Post Market risk assessments.

+ Management of Field Action Determinations.

+ Assists with explaining project information or processes in a regulatory or supplier audit.

+ Performs other duties as requested.

**Required Qualifications**

+ Bachelors degree in Engineering or related field and/or equivalent experience

+ Minimum of 2+ years of experience

+ Proficient in Microsoft Office Suite applications

**Competencies Required**

+ Strong organizational skills with ability to promote team interaction and execution

+ Excellent written and oral communication skills

+ Must have the ability to initiate and develop creative solutions

+ Possess outstanding customer service skills and be self-motivated

**Additional Information**

+ Monday Friday / 9am 5pm EST

+ Remote position

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone ( ) for immediate consideration.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2022-05-13 Expires: 2022-06-13

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Systems Engineer

Kelly Services
Cary, NC 27512

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