Systems Engineer - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 7/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:
    7/13/2019

Job Description

Position Overview:

The systems engineer will develop and maintain technical documentation related to the Design History File of complex electro-mechanical software driven medical devices.  The system engineer will lead and participate in cross-functional teams that focus on requirements engineering, risk management, verification/validation, and reliability assurance.  The systems engineer will ensure that development and remediation activities are compliant with internal development processes and regulatory requirements specifically 21 CFR 820.30.  The role requires an individual with strong organization, communication and technical writing skills, with the ability to effectively interface with both technical and non-technical personnel.

Job Details:

  • Develop and maintain Design Inputs documentation, including system-level requirements, product specifications, traceability matrices, and test to specifications.
  • Develop and maintain Risk Management documentation, including plans, hazard identification, hazard analysis, design failure mode and effects analysis (DFMEA), and reports.
  • Develop and implement system-level design verification and validation concepts.
  • Develop and implement system-level reliability assurance concepts, including accelerated life testing.
  • Mentor junior Systems Engineers.
  • Work with cross-functional teams, in a team-member and leadership role, to ensure the timely release of critical deliverables.

Background Experience:

  • BS in Systems, Biomedical, Electrical, or Software Engineering with 10+ years of related experience
  • MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 7+ years of related experience
  • Excellent problem-solving, design, and technical skills
  • Lead and manage technical meetings with cross-functional team members
  • Knowledge of requirements development, traceability, and allocation
  • Knowledge of medical device risk management, including ISO 14971:2012
  • Knowledge of ISO 13485:2016.
  • Knowledge of design verification and validation concepts, including the planning and execution of system-level testing of medical devices
  • Medical Device experience including thorough understanding of Design Controls (21 CFR 820.30).
  • Working knowledge of FDA and International Standards requirements as related to capital equipment
  • Experience with Requirements Management Tools (such as CaliberRM)

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.