Centerline Biomedical

Recruiter Contact
Darwin Shurig

Chief Executive Officer

A New Way to Envision Interventional Navigation


Medical Equipment Manufacturing


Cleveland, OH

We are pioneers in surgical navigation and precision healthcare, empowering physicians with safe, real-time, imaging solutions that improve outcomes, lower costs, and reduce radiation exposure for both patients and caregivers in minimally invasive endovascular procedures.   Delivering on our commitment to improve quality of life by changing the way healthcare is delivered, our multidisciplinary team of scientists, clinicians, engineers, and software architects has developed the Intra-Operative Positioning System (IOPS™). This mobile and affordable GPS-like 3D vascular navigation system allows for greater surgical precision and control than ever before, improving device placement accuracy, simplifying complex procedures, and potentially decreasing endoleaks and costly secondary interventions.   Centerline Biomedical, Inc. was founded in 2014 as a spinoff of the Cleveland Clinic to commercialize our innovative vascular navigation technology. With a research, development, and design history rooted in the Clinic’s world-class Lerner Research Institute’s Heart and Vascular Institute, the IOPS™ platform can be further used for predictive modeling, clinical decision support, global healthcare analytics and the education and training of future surgeons and interventionists
A Message From The Centerline CTO and Inventor

The Opportunity

Systems Engineer

Cleveland, OH
  • Overview & Responsibilities

    The Systems Engineer shall be responsible for the following activities/job functions:

    ● 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.

  • Qualifications

    Bachelor’s Degree with 3+ years of medical device development experience is highly desirable.


    Skills and Abilities Required:

    ● Involvement with medical device regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and ISO 13485 including experience with system risk/hazard analysis
    ● Experience with FDA 510(k) product/testing requirements
    ● Excellent IT/computer skills and a willingness to learn new tools as they become relevant
    ● Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision
    ● Ability to work efficiently on multiple tasks with deadlines
    ● Ability to work in a diverse team with members of varying education and experience levels
    ● Creative/innovative, able to rapidly problem-solve and work well given typical project schedules
    ● Superb organizational and multitasking skills as well as strong written and verbal communication skills
    ● Familiarity with ISO and IEC standards pertaining to medical devices
    ● Proficiency with functional analysis and cascading down from user level to subsystem/ component level of customer requirements
    ● Experience working in Quality or Regulatory capacities in the medical device industry
    ● Skilled in developing test plans and validation protocols in a regulated environment
    ● Capability of using automated software testing tools
    ● Familiarity with numerical analysis and methods
    ● Ability to work effectively in a multidisciplinary team while maintaining independence from technical development
    ● Strong analytical skills and willingness to develop understanding of relevant concepts in medicine and mechanical, electrical, and materials engineering
    ● Demonstrable experience in performing risk assessment, software validation and testing


Building career-spanning relationships, from candidacy to organizational leadership, we provide access to the future of the Medtech and Pharma.