MEDVACON is conducting a search for our leading Medical Device client in Columbia, MD
Hiring for mid and Sr. level Bio-Medical Engineers on-sie in Columbia, MD
RISK MANAGEMENT ENGINEER
Create, Review and Update as needed:
FTA, uFMEA, dFMEA, sFMEA, pFMEA risk assessments
Subject matter expert on risk based design lifecycle for system
Implement, collaborate, lead, interface and author risk management quality documentation
Perform risk assessment as part of post-market monitoring in support of complaint risk analysis, field corrective actions, design changes, maintenance efforts, and supplier risk assessment evaluation and manufacturing non-conforming materials
Well versed with medical device FDA and EU regulations, and all the necessary steps for risk management documentation
• Longer-term improvement opportunities for the organization will be to centralize and improve the risk analysis documentation and completion efficiency such as selecting, deploying and configuring risk management tools
• Daily tasks for this role will be based around risk management documentation, risk analysis, failure mode effects and analysis, authoring risk controls and traceability mapping for identified risk controls including their verification of effectiveness, risk based V&V method , residual risk review and risk benefit analysis
Product DHF risk management files shall be organized in order to support successful regulatory submission when working with the regulatory teams for FDA submission
• Partner with other functions in the organization to ensure stakeholders requirements are addressed provide consistent communication with cross functional teams and encourage a spirit of risk management collaboration throughout the project team and organization
Applies flexible and novel approach to solve problems or optimize solutions in complex or cross functional product development and manufacturing
• Support risk management audits, as a subject matter expert, when working with external business partners and where needed regulatory authorities
• Perform other duties as assigned by supervisor
Minimum Bachelors in Science, Engineering or Technical Discipline
Minimum 6-8 years risk management design control medical device experience
Software: Minitab, SolidWorks, (Basics), Microsoft Office
Design Quality Risk management implementation - Regulatory Knowledge and Experience:
ISO 14971, 13485
Please attach a WORD resume to your on-line application.
This is a 2 year contract assignment on-site in Columbia, MD. NOT a perm job.
No expenses or benefits are available for this assignment.
No! Agencies please do not submit your candidates. NO C/C with other employers.
W2 or 1099directly with a consultant only.
All your information will be kept confidential according to EEO guidelines.