Risk Management Job Listing at PDS Tech Inc in Newark, DE (Job ID 14004443)
PDS is seeking a Systems Engineer 2 for an open position in Newark, DE.
In your role, you will:
Compose Risk Management Plans and Risk Management Reports.
Lead Risk Status Reviews and facilitating risk evaluations.
Perform risk assessment, evaluation, control of Hazards including narrative content, ranking frequency, severity, and identifying cause(s).
Make recommendations for risk reduction options, and update risk action plans as needed.
Maintain awareness of ISO 14971/FDA Medical Device Risk Management requirements, industry developments and participate in professional meetings, and may author related publications.
As our ideal candidate, you will meet the following requirements:
BS Degree in engineering/chemistry/science, minimum of 10 years of experience working in the Medical Device industry.
At least 2 years of experience should be in a clinical/hospital environment.
Experience in hospital and/or clinical laboratory and with software packages like TFS and/or Teamcenter-RE are strongly preferred.
Must be able to work in a fast-paced team environment and adapt to rapidly changing requirements.
Ability to extract information from clinical documentation. (Experience in medical/clinical terminology).
Excellent verbal and written communication skills.
Expertise or significant experience using Risk analysis tools such as FMEA, FTA, FMECA, Hazops is essential.
Understanding Risk Analysis of Software Systems and Proficiency with Microsoft Office (Excel, Word, Powerpoint) are also necessary.
Apply on Company Website
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