Chief Executive Officer
A New Way to Envision Interventional Navigation
Systems EngineerCleveland, OH
Video with Hiring Manager
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.
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
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