Lake Forest Lake Forest , IL 60045
Job Title : Lead Engineer
Location : Lake Forest, Illinois, US - 60045
Job Type : Contract To Hire(Potential For Extension)
Duration : 12 Months
About Our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives.
- Bachelor's degree or MS in Mechanical Engineering / Bio Medical Engineering and 4 – 8 year’s overall experience is preferred
- Experience in working in Consumable Medical devices, Combination Products and knowledge in medical device quality process.
- Should have worked in medical new product development projects & sustenance projects.
- Experience with System Engineering processes, such as requirements traceability and using tools such as, DOORS.
- DXL scripting is added advantage.
- Experience in change control process.
- Should have worked in ISO 13485 / 21CFR820 (design control processes)/ ISO 14971 compliant environment.
- Should understand Risk Management activities (Risk Management Plan, Hazard Analysis, User Error Risk analysis, FMEA & Risk Management Report) for Consumables (IV Administration sets, syringes, etc.) per ISO 14971 standard.
- Lead and manage risk management activities for post market surveillance analysis.
- Understand and create linkages between risk management files and complaint code specifications.
- Provides written reports and engineering documentation by following cGMP practice.
- Ability to review and analyze engineering reports / documentation.
- Experience in verification, validation or other rigorous testing and lab processes design to document conformity as common in a regulated environment.(Preferred, Not Mandatory).
- Exposure to Human Factor Engineering (Preferred, Not Mandatory).
- Excellent written and verbal communication is a must.
Key Words To Search:
- ISO 13485 / 21CFR820 (design control processes)/ ISO 14971 compliant environment.
- Requirements Study-URS, PRS, Hazard Analysis, dFMEA, UERA, Risk Management Plan.
- cGMP practice, post market surveillance and Human Factor Engineering.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
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