Principal Systems Engineer - Risk Management Job Listing at Kelly Services in Norcross, GA (Job ID US3630729_BH10035201)

Description

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a Direct Hire opportunity to work as a Principal Systems Engineer  located in Norcross, GA.
 

Job Title: Principal Systems Engineer – Risk Management
Location: Norcross, GA
Employment Type: Full-Time, Direct Hire
Work Model: Onsite initially; hybrid schedule (3 days onsite / 2 days remote) available after ramp-up
Compensation: $130k-$150k
Sponsorship: Not available

About the Role

We are seeking a highly experienced Principal Systems Engineer to lead risk management activities for complex diagnostic systems within the Transfusion & Transplant product portfolio. This position is responsible for developing, maintaining, and owning all risk management documentation—including System Hazard Analyses (SHA) and Design Failure Mode and Effects Analyses (dFMEA)—while partnering closely with cross-functional teams across R&D, Quality, and Operations.

This is a high-impact role with significant visibility, offering the opportunity to support innovative diagnostic platforms and contribute to long-term product safety and compliance.

Key Responsibilities

• Lead the creation, development, and maintenance of comprehensive risk management files for new and existing products.

• Collaborate cross-functionally to gather technical inputs required for risk documentation.

• Develop system modules supporting architecture decisions, requirements development, tolerance allocation, and risk planning.

• Apply broad technical expertise in mechanisms, fluidics, electronics, and instrumentation to support design feasibility, test method development, and system characterization.

• Design and analyze experiments using DOE and statistical tools; translate findings into actionable design recommendations.

• Lead or support the design of fixtures, test stations, and validation tools.

• Participate in new product development, design improvements, and competitive product assessments.

• Provide technical oversight to OEM partners during design evolution.

• Mentor Systems Engineering team members as needed.

Required Qualifications

• BS in Engineering required (Mechanical or related discipline preferred); MS/PhD strongly preferred.

• 8+ years of experience in product development or systems engineering, including 5+ years in medical devices.

• Hands-on experience authoring System Hazard Analyses (SHA) and dFMEAs.

• Deep understanding of ISO 14971, FDA Design Control, ISO requirements, GMP, and design transfer.

• Experience with instrument automation or scientific instrumentation.

• Strong analytical, organizational, and problem-solving skills; able to manage multiple priorities.

• Effective communicator with the ability to collaborate across diverse technical teams.

Preferred Qualifications

• Background in in-vitro diagnostics (IVD) or immunology-based systems.

• Experience with automated testing systems.

• Demonstrated passion for risk management.

• Design for Six Sigma (DFSS) experience.

• Experience with system modeling, simulation, and requirements development from user needs.

APPLY NOW FOR IMMEDIATE CONSIDERATION!!

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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 for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.

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