Job Summary

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.

Responsibilities

This role provides technical leadership to project teams to ensure interdisciplinary integration is met. This position is responsible for considering the complete solution across the entire lifecycle of the product. These areas of responsibilities typically include:

• 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

• 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.

Key Qualifications

• 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.

Preferred Qualifications

• 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).

Compensation Data

Battelle is committed to fair and equitable compensation practices. The salary range for this role is $128,800 - $183,600 per year, in addition to our comprehensive benefits package. A candidate's salary is determined by various factors, including but not limited to education, relevant work experience, skills, and certifications. Salary ranges may vary based on geographic location and market conditions.

Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.

• Balance life through a compressed work schedule: 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.
• Enjoy enhanced work flexibility, including a hybrid arrangement: You have options for where and when you work. 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 .
• Take time to recharge: You get paid time off to support work-life balance and keep motivated.
• Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
• Better together: Coverage for partners, gender-affirming care and health support, and family formation support.
• Build your financial future: Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.
• Advance your education: Tuition assistance is available to pursue higher education.