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Systems Engineer III | St. Louis, Missouri

Full-time | Contract | Onsite

Kelly® Engineering is seeking a Systems Engineer III to support development of a new ophthalmic surgical system (including electromechanical console and compatible accessories) for our biomedical client in St. Louis, MO. This role is expected to be a 6-month contract position.

The candidate, in collaboration with regulatory, quality, and R&D SMEs on the mechanical and electrical teams will complete definition of requirements and FMEAs for the system and help prepare documentation for verification activities. Candidate is expected to be competent at requirements development, risk analysis, and test case writing for integrated medical systems and have a deep familiarity with the relevant regulations and international standards.

At this phase of the project, the largest areas needing support are finalizing labeling requirements, writing requirements for PCBs and tests for those requirements, and completing system-level DFMEA and harms-based risk analysis updates. Experience in at least one of those areas is required.

Key Responsibilities

• Read, understand, and interpret applicable industry standards and government regulations.

• Distill testable requirements from partial to complete designs and SME knowledge.

• Perform risk analysis at component and system levels and generate relevant design mitigations.

• Assist in test development for system, surgical functions, and accessories.

• Respond to integration & test issues with the best plans for rapid correction.

• Adjust drafted requirements for subsystems of medical devices. Determine strategy and needs for life testing, reliability testing necessary to hit design goals.

• Use Aras PLM to create traceability between design inputs, design outputs, design documentation, regulatory standards, risk items, mitigations, and architecture.

Minimum Qualifications/Education

• BS in Engineering (Systems, Biomedical, Electrical, Mechanical)

• 7+ years experience as an engineer.

• Proven track record of launching complex electro-mechanical systems with a high regulatory burden.

• Experience with risk analysis, requirement management, and verification planning. Excellent communication & organizational skills.

• High degree of self-motivation and direction.

Preferred requirements:

• Successfully launched a surgical medical device

• Deep familiarity with the relevant regulations and industry standards (FDA, MDR, CA, UKCA, ISO, IEC, ETSI, etc...).

• Experience using Aras PLM

• Familiarity with medical device labeling

All applicants applying for this job opening must be legally authorized to work in the United States and are required to have US residency at the time of application.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.