Systems Engineer, Remediation, Defined Term - Mahwah, NJ in Mahwah, NJ at Getinge

Date Posted: 7/5/2018

Job Snapshot

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

Job Description

Position Overview:

The systems engineer will remediate 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 remediation activities are compliant with internal development processes and regulatory requirements.  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:

  • Remediate and maintain Design Inputs documentation, including system-level requirements, product specifications, traceability matrices, and test to specifications.
  • Remediate and maintain Risk Management documentation, including plans, hazard identification, hazard analysis, design failure mode and effects analysis (DFMEA), and reports.
  • 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 7+ years of related experience
  • MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 5+ years of related experience
  • Excellent problem-solving, design, and technical skills
  • Lead and manage technical meetings with cross-functional members
  • Knowledge of requirements development, traceability, and allocation
  • Strong working knowledge of ISO 13485:2016; FDA 21 CFR 820.30, ISO 14971:2012.
  • Ability to be a key contributing member of cross-functional development teams
  • Excellent interpersonal, verbal, and written communication skills.

This is a “Defined Term” assignment that will last approximately 12 months or until project is complete.  Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

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.