Systems Engineering Analysis, Senior

We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency.
Systems Engineer to support our medical device development projects. This position located in Columbus, OH and open to Remote.
Battelle’s Medical Devices and Health Analytics Business Line is hired by external companies from startups to Fortune 100 to assist them with their product development needs. A significant portion of our work is focused on developing medical devices. This has included projects for mass produced drug delivery devices, immunodiagnostic systems, surgery tools, large scale imaging systems, and more. The Senior Systems Engineer provides the interdisciplinary oversight and guidance to the project teams to ensure the product being developed meets the customer’s needs within the constraints set by the client, the technology, and the industry regulations.
This role provides technical leadership to project teams to ensure interdisciplinary integration is met. Technical planning
Responsible for management of technical requirements, risk, and integration plans
Supports the creation of of project schedules, level of effort, project plans, time, cost, tasks
mech, elec, software, usability, cybersecurity, etc.)
Generation of system architecture (collaborating with electronics architect and software architect), including: Development and maintenance of system level and subsystem requirements documents including allocation, traceability, and integration.
Risk management
Generation and maintenance of (including gathering appropriate input into) hazards analyses, failure modes and effects analyses (design, user, production), fault tree analyses, safety assurance cases, cybersecurity risk assessments, Reliability analyses, etc
Testing / verification including use of appropriate statistics methods, design of experiments, selection of appropriate test methods, identification of test equipment requirements, test execution, and test result documentation and analyses.
Regulatory & standards compliance
Supports compliance to our ISO 13485 registration
Consults with clients on long-term projects
Recognized by clients as an expert in one or more specific areas of engineering
Bachelor’s degree discipline relevant to product development with 8 years of experience or master’s degree in related field with 5 years of experience or PhD with 2 years of experience; or an equivalent combination of education and or experience in a related field.
Demonstrated track record of successful product development on dynamic projects across multiple disciplines.
Proven abilities in leading cross functional technical teams, managing risk, and adapting to change.
Experience in data analysis, statistical analysis, design of experiments, and process mapping.
Familiarity with standards such as IEC 60601, ISO 11608, ISO 10993, IEC 62368-1, or other particular product safety or performance standards.
Possess specialized expertise in one or more technical domains that provide a technological edge in the design, performance, or implementation of new medical devices. Example areas of expertise may include, but are not limited to: project management, microfluidics, optics, electrochemistry, embedded systems, fluid dynamics, physiology, multi-physics simulation or modeling, implantables, sensor design, automation.
15 years of new product development experience, with at least 10 years in medical products.

• An advanced degree in Engineering, Science, or Business.
• Experience working under an ISO 13485 registered quality system.
• Experience with ISO 14971 and/or experience in conducting safety risk management activities (e.g. Hazard Analyses, FTA, and various FMEAs).

Compensation Data
A candidate’s salary is determined by various factors, including but not limited to education, relevant work experience, skills, and certifications. Battelle offers comprehensive and competitive benefits to help you live your best life.
Most of our team follows a flexible, compressed work schedule that allows for every other Friday off—giving you a dedicated day to accomplish things in your personal life without using vacation time.
Our Together with Flexibility model allows you to work 60% in-office and 40% remote, with Monday and Tuesday as common in-office days, dependent on team and position needs.
Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
Build your financial future : Build financial stability with an industry-leading 401(k) retirement savings plan. For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.
Apply your talent to challenging and meaningful projects
Receive select funding to pursue ideas in scientific and technological discovery
Nurture and develop the next generation of scientific leaders
Give back to and improve our communities
If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws).
We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.