Systems Engineer, Software Risk Specialist - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 7/13/2019

Job Snapshot

  • Employee Type:
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Position Overview:

The Systems Engineer (Software Risk Specialist) will drive product quality, safety, design and reliability through the cross-functional teams and into the product. The Systems Engineer will have direct influence on software and system product quality and will work closely with software development engineers and cross-functional teams to define internal software risk processes and conduct software risk analysis. They will actively participate in review of software requirements and architecture designs; thereafter derive software risk analysis and suggest risk mitigations/control measures. The hired candidate may also be involved in supporting other Systems Engineering deliverables including system risk management, verification/validation and design traceability. 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 Duties:

  • Develop and maintain Software Risk Management Documents.
  • Participate in assessment of Cybersecurity Risk Assessment.
  • Review software designs and documents as they pertain to Software Risk.
  • Participate in cross-functional reviews to ensure that software risks are mitigated through the development process.
  • May update System Level Risk Management including update to plans, hazard identification, hazard analysis, design failure mode and effects analysis (DFMEA), and reports.
  • Develop and implement updates to system-level design verification and validation concepts.
  • 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, or Software Engineering with 7+ years of related experience
  • MS or PhD in Systems, or Software Engineering with 4+ years of related experience
  • Knowledge of medical device software risk management, including ISO 14971:2012 and AAMI TIR 80002-1.
  • Knowledge of ISO 13485:2016
  • Excellent interpersonal, verbal, and written communication skills.

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.