Systems Engineer

Job Description

Job Description

Position Summary :

The Systems Engineer is an Exempt / Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures. The role assists in system risk analysis, as well as identification, prioritization, and documentation of customer needs and requirements. The Systems Engineer develops system and sub-system interface requirements that assure the completed system meets required functionality. Together with the development team, the Systems Engineer is responsible for investigation, evaluation, and selection of the best system structure and documentation.

Responsibilities / Duties :

• Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.
• Develops / maintains system architecture and interface requirements for the products, based on technology and platform strategies.
• Defines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.
• Implements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements.
• Responsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.
• Develops / maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC 60601-1 and its appropriate subparts.
• Works with other team members and functions to execute design reviews of complex Medical Devices.
• Drives structural design documentation and plans by applying engineering best practices.
• Conducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.
• Effectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.
• Understands and follows quality and product development processes.
• Incorporates business, market, industry, and competitive knowledge into technical solutions.
• Determines required tasks and completes on time with minimal supervision.
• Identifies and communicates potential risks with appropriate mitigations.
• Synthesizes complex information gathered from a variety of sources and disseminates to others.
• Additional duties as assigned.

Minimum Qualifications, Education, and Experience Required

Education and Experience :

Abilities :

Work Conditions :

Work is performed primarily in a standard office environment.  Essential functions require sufficient physical ability and mobility to work in an office setting; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push / pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard).  Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).

Centerline Biomedical is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions, and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Centerline Biomedical will be based on merit, qualifications, and abilities. Centerline Biomedical does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.