Sr. Systems Engineer

Battelle•Columbus, OH

5d•$128,800 - $183,600•Hybrid

About The Position

Battelle delivers when others can’t. 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. We recognize and appreciate the value and contributions of individuals from a wide range of backgrounds and experiences and welcome all qualified individuals to apply. We are currently seeking a Sr. 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. Clients choose to work with us because of a proven track record for developing innovative and marketable solutions to challenging technical problems. 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. Regardless of whether the device is in the user’s hands or part of a larger system of care, they all are driven by the same ambition - to positively affect the user’s health outcome. 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.

Requirements

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.
Self-motivated, organized, and a problem solver who demonstrates knowledge of fundamentals but also the big picture.
Excellent communication skills to support interaction with cross-functional team members, internal management, and clients.
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.

Nice To Haves

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 registering products through FDA regulations (such as 510(k)).
Experience with ISO 14971 and/or experience in conducting safety risk management activities (e.g. Hazard Analyses, FTA, and various FMEAs).

Responsibilities

Provides technical leadership to project teams to ensure interdisciplinary integration is met.
Responsible for considering the complete solution across the entire lifecycle of the product.
Technical planning
Responsible for management of technical requirements, risk, and integration plans
Supports the creation of project schedules, level of effort, project plans, time, cost, tasks
Technical execution
Oversight of the technical team's tasks (incl. mech, elec, software, usability, cybersecurity, etc.)
Manages conformance to applicable processes, standards and regulations
System architecture
Generation of system architecture (collaborating with electronics architect and software architect), including: Functional block diagrams, Boundary diagrams, Context diagrams
Requirements management
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.
Build management
Plans and coordinates limited volume prototype builds.
Regulatory & standards compliance
Supports compliance to our ISO 13485 registration
Contributes to our knowledge of FDA regulations and their impact on design requirements
Client Interaction
Builds relationships with internal and external clients
Prepares and presents reports / results to clients, stakeholders, regulators, and in public forums as necessary
Manages client meetings
Consults with clients on long-term projects
Recognized by clients as an expert in one or more specific areas of engineering
Continual Improvement
Supports the culture of continual improvement in our processes, capabilities, and our people.