Centerline Biomedical

Systems Engineer

Centerline Biomedical

full-time

Posted on:

Location Type: Hybrid

Location: Cleveland • Ohio • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • 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.

Requirements

  • Bachelor’s degree with 3+ years of medical device development experience is highly desirable
  • 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.
Benefits
  • Equal opportunity employer
  • Strong support for diversity in the workplace

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
system engineeringsystem architectureinterface requirementsrisk managementimpact analysistest plansvalidation protocolsautomated software testingnumerical analysissoftware validation
Soft skills
problem-solvingorganizational skillsmultitaskingcommunication skillsflexibilityself-startingcreativityteamworkanalytical skillsindependence