Systems engineer serp_jobs.h1.location_city

Systems Engineer (Cincinnati, Ohio)

Our client, a global leader in the medical device industry, surgical solutions, is currently hiring two Systems Engineers, range of experience- one candidate with 4-8 years’ experience and one with 5-15 years would be ideal. Positions are new role due to growth, client's internal team is on a hiring freeze, until lifted, roles will be a fully benefited Kelly Engineering Consultants.

Job Summary :

The Senior Systems Engineer will lead the design and development of medical devices, making sure they meet user’s needs and safety standards. This person will work closely with customers to understand what’s needed, help plan and test devices, and coach teammates. Additionally, they’ll help manage parts of projects like budgeting and schedules, and make sure everything runs smoothly and meets regulations.

Skills with systems requirements, requirement management for regulatory products, experience in requirements management, usability engineering, risk analysis, and systems architecture all crucial. Industry preference in this order : Medical Devices or Aerospace or Automotive or Biomedical or Pharma.

Description :

The Senior Systems Engineer will lead the design and development of medical devices, making sure they meet user’s needs and safety standards.

Essential Functions :

This person will work closely with customers to understand what’s needed, help plan and test devices, and coach teammates. Additionally, they’ll help manage parts of projects like budgeting and schedules, and make sure everything runs smoothly and meets regulations.

Primary Responsibility :

Lead requirements management for medical device projects.

Responsibility for leading the design, development, and validation of complex hardware and software systems with a focus on medical devices. This includes defining user needs, system architecture, requirements management, risk analysis, usability, and regulatory compliance. Additionally, this role involves providing guidance and mentorship to less experienced team members and contributing to project management activities.

Accountabilities / Responsibilities :

Owns and manages requirement documentation and traceability processes.

Develop user needs through Voice of Customer processes.

Translate customer input into technical requirements.

Evaluate change requests for impacted requirements and rationalize testing strategies.

Support and contribute to risk management processes.

Secondary Responsibilities :

Lead usability evaluations with customers.

Conduct internal and external usability evaluations.

Create Human Factors Engineering reports.

Assist in planning and executing verification & validation activities.

Additional Responsibilities :

Performs system architecture design and functional flow analysis.

Understand product lifecycle and contribute to business development planning.

Provide guidance and mentorship to less experienced team members.

Contribute to aspects of project management including scope definition, scheduling, budgeting, and contingency planning.

Required Skills / Experience :

Demonstrated experience in requirements management, risk analysis, and usability.

Minimum of 3-4 years relevant experience, minimum of 5 years in systems engineering within the medical device industry strongly preferred (the right candidate in aerospace, automotive or other life science may be considered).

Strong background in requirements management—writing, organizing, and tracking technical requirements.

Hands-on experience in risk analysis and problem-solving for complex systems.

Skilled at conducting usability evaluations and translating customer feedback into design improvements.

Familiarity with regulatory standards (compliance for medical devices a huge plus).

Project management skills, including scheduling, budgeting, and planning.

Education :

Bachelor’s degree in Engineering, or related field strongly preferred (i.e., Systems, Mechanical, Biomedical).

Advanced degree in the field is desirable but not required.

Join a collaborative, mission-driven culture making a tangible impact on women’s health, apply today and come work for a company immersed in innovative medical devices that is dedicated to advancing healthcare and patient outcomes. Take pride knowing you work for a company that, over the past 25 years, their innovations have saved lives for more than 10 million women worldwide.

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