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Medical Device Engineer

Company: Automated Systems, Inc.
Location: Deerfield
Posted on: June 15, 2022

Job Description:

Medical Device Engineer - Product Development Job Role Summary Contract: 12 months Location: Deerfield, IL ( Onsite (hybrid) - Responsible for supporting the development of new products and on-market products used in surgical procedures. This person should be able to work in a matrix environment through partnerships with R&D and other cross functional team members. This position is in need of a strong understanding of Quality Compliance by building quality into products using design control and risk management principles in compliance with regulatory standards and procedures. Essential Duties and Responsibilities: --- Applies state of the art techniques in the area of expertise to support the development of new or improved products --- Supports the sustainability and life cycle management of existing products --- Ensures compliance with global quality systems and Regulatory requirements related to product and process --- Provides Quality Assurance support and guidance for verification and validation of product requirements --- Performs design change control activities including impact assessments, reviews, and approvals --- Takes lead role in CAPA activities such as investigation, implementation, or verification of effectiveness --- Supports risk management activities as they relate to product and post market surveillance --- Interacts with on-shore and off-shore suppliers to complete project related activities --- Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products --- Plans, executes, and works with minimal supervision and independent judgment Requirements Qualifications: --- Must have experience working with all classes of Medical devices preferably implantables, Biologics, and combination products with advanced training and demonstrate proficiency in problem solving, total quality management, DHF remediation, Risk file remediation, EUMDR, problem analysis and resolution, and design of experiments. --- Experience with new product development activities as R&D lead or QE lead in various product development teams. --- Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls. --- Extensive cross-functional team experience, including technical and non-technical work. --- Strong interpersonal, communication, influencing, and negotiation skills. Education and Experience: --- B.S. degree in Engineering with at least 1-3 years of experience working in a regulated environment. --- Higher degrees desired with relevant experience in medical device industry. --- Demonstrated success in delivering results on several technical challenges. --- Working knowledge of medical device international standards. --- top technical skill requirements: Product life cycle management experience, medical device experience, design development and transfer experience --- top soft skill requirements: good verbal and written communication, hard worker, curious to learn new things, critical thinker Job Requirements:

  • Maintain and repair biomedical equipment
  • Document quarterly preventative maintenance on biomedical equipment
  • Check work of the biomedical technician
  • Supervise and coordinate activities of biomedical equipment technicians
  • Provide safety testing, repair, and maintenance of biomedical equipment
  • Evaluate the safety, efficiency, and effectiveness of biomedical equipment
  • Define, develop and manage the delivery of the organization's biomedical engineering equipment management program
  • Use basic anatomy and physiology knowledge as apply to use of biomedical equipment
  • Entail using knowledge of electronic engineering, biomedical engineering, computer programming, feedback control theory, and microprocessors to produce biomedical instrumentation systems to measure physiological parameters
  • Adjust, maintain, repair, or provide technical support for biomedical equipment
  • Assist with product design and help to develop safety testing, repair, and maintenance requirements for biomedical equipment
  • Ensure that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards
  • Assist with proposal development and white paper generation related to biomedical engineered solutions
  • Correct malfunctions on a variety of medical equipment systems
  • Interpret schematics, wiring diagrams, and illustrated parts drawings of biomedical instrumentation
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products
  • Ensure that the biomedical engineering department staff are actively engaged in the creation and adherence to the departments mission and vision
  • Display a broad knowledge of medical equipment and application to sophisticated medical systems and procedures
  • Supervise, direct, evaluate, and delegate work and responsibilities to biomedical personnel
  • Completing and maintaining all performance indicators at or above program targets

Keywords: Automated Systems, Inc., Arlington Heights , Medical Device Engineer, Other , Deerfield, Illinois

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