Principal Reliability Engineer at Bedford

Job Description

About our Client:

Our client is a global leader in the Medical Device industry focusing on cutting edge technology for evasive surgery.

Job Description:

The Principal Reliability Engineer will report to Engineering Leadership and be tasked with follow-through of New Product Development for an established global medical device company. The Principal Reliability Engineer will oversee the reliability and test implementation for all areas of Engineering including Design, Mechanical, and Manufacturing. The Principal Reliability Engineer will also provide support for a Design For Reliability (DFR) Program for new and sustaining development projects and new or modified technology

• Create Reliability Plans plans based on FMEA, Stress Analysis, and Fault Tree Analysis
• Perform validation/verification testing in compliance with Quality regulations (IQ, OQ & PQ)
• Generate test plans and execute tests to verify performance of components and/or products to specifications, in particular PCB technology
• Conduct HALT/HASS strategies and testing for IEC 60601
• Participate in reviewing specification for components and processes.
• Corrective action planning involvement, as well as failure analysis and root cause analysis
• Technical support of ISO 14971 system
• Data set-up sheets, corrective action and control charts to improve capabilities
• Manage capital projects associated with the manufacturing process
• Statistical process knowledge with an understanding of methods improvement

Who were looking for:

The Principal Reliability Engineer must have:

• BS in Mechanical or Electrical Engineering
• 7-10 years of Reliability or Test Engineering Experience
• Knowledge of FDA Regulations (ISO 13485 or 14971)
• Experience with leading a quality change system
• Lean Manufacturing Experience; Six Sigma Certification a plus
• Track Record of successfully leading projects to completion
• Strong background in electro-mechanical systems is a big plus
• Excellent communication and organizational skills

Whats on offer:

• Competitive base salary
• Outstanding compensation package
• 401k

Job Requirements

 
Country: USA, State: Massachusetts, City: Bedford, Company: Michael Page.