Risk Management Engineer

Collabera
US - Minnesota - St Paul
July 4, 2024

Description

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Risk Management Engineer

Contract: Saint Paul, Minnesota, US

Salary: $70.00 Per Hour

Job Code: 351098

End Date: 2024-07-25
Days Left: 19 days, 3 hours left

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Duties:

A Senior Risk Management Engineer assures new products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is
appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Product Development - support/execute risk management plan
Support system/product risk management planning
Support the requirements development process to assure quality of requirements and linkage to risk management file
Support/lead System Hazard Analysis; support risk assessments (FTAs, FMEAs);
Analyze and incorporate legacy inputs; coordinate/integrate cybersecurity risk with patient safety implications
Assure and maintain traceability among hazards, risks, risk analyses, evaluations and risk controls, and verification of implementation and effectiveness of risk controls
Support/lead writing of system/product risk management reports
Be point of contact for tracking and developing response to post market signals (event-based and periodic) and lead resulting risk management file updates Including annual risk file updates
Complaint analysis and related action planning/response
Backroom support for audits
Risk Management Tool Mastery
Develop proficiencies in primary risk assessment tools (e.g., FMEA, FTA)
Support Risk Management Process Excellence
Identify opportunities for improvement and drive/support process/infrastructure changes
Identify/support process improvements driven by changes to external regulations, standards, or guidance or by internal Quality Policies
Support CAPA efforts with linkages to Risk Management Process or Execution
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Education/Experience: Required:

Bachelor level degree in Engineering or Technical Field
5+ years' experience
Previous design quality engineering experience and demonstrated use of quality tools/methodologies
Experience working in a broader enterprise/cross-division business unit model

Preferred Qualifications:

Advanced Degree
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model
Working understanding of FDA, GMP, and ISO 13485
Working understanding of the following standards: ISO14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155
Systems or clinical engineering experience
Experience with basic statistics and/or reliability methodologies
Experience facilitating risk assessments (e.g., FMEAs or FTAs)

Job Requirement

Risk Management
CAPA
FDA
GMP
and ISO 13485
Documentation
FMEA/FTA

Reach Out to a Recruiter

Recruiter
Email
Phone
Vishnu Nair
***

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Read the full job description and apply online on the recuiter's web-site

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