Senior Design Quality Engineer

Location: Marlborough, MA Salary: $110,000.00 USD Annually - $135,000.00 USD Annually Description: Our client is currently seeking a Senior Design Quality Engineer .
This a full-time permanent role with competitive salary + bonus and benefits like 401k match, dental, vision etc.
This job will have the following responsibilities:

• Conduct product design control activities for both new product development and sustaining engineering projects.
• Support risk management activities, including Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA).

Participate in design and process verification/validation activities, including:

• Design Verification (DV)
• Design Validation (PV)
• Software Validation
• IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification)

Support Design Engineering in the development and maintenance of:

• Design History Files (DHF)
• Technical Files
• Design specifications
• Verification and validation documentation

Qualifications & Requirements:

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Electrical Engineering degree preferred.
• 5+ years of experience in the design and development of Class II electro-mechanical medical devices.
  
• Experience working within FDA-regulated and ISO-compliant medical device environments.

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