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Company:
Collabera
Posted: July 4, 2024
Description
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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
Apply
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.
- 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
- 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)
- Risk Management
- CAPA
- FDA
- GMP
- and ISO 13485
- Documentation
- FMEA/FTA
- Recruiter
- Phone
- Vishnu Nair
- ***
Read the full job description and apply online on the recuiter's web-site
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