Design Assurance Engineer (Medical Device)

Hello

Hope you are doing well.

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to [email protected] or call me at +1(732)-276-2791.

Role: Design Assurance Engineer

Location: St. Paul, MN - 55117

Duration: 5 Months

Shift Timings: 8 AM to 5 PM

Job Description

The Design Assurance Engineer ensures that products meet quality standards and regulatory compliance. This role collaborates with various departments, including development, manufacturing, quality engineering, and regulatory affairs, to monitor and improve the quality system.

Responsibilities

• Ensure compliance with the Quality System and GMP/ISO standards.
• Lead design assurance activities for electromechanical systems, including microcontroller technology, PCBs, and software.
• Manage and maintain Design History Files for new products.
• Collaborate with Engineering, Marketing, Manufacturing, and Regulatory teams to establish product requirements.
• Define and document test equipment, protocols, procedures, and reports.
• Conduct tests and perform risk management and analysis, including FMEA.
• Develop design verification and validation plans.
• Analyze and communicate conformance to specifications and standards.
• Conduct technical and statistical investigations for compliance and optimization.
• Support in vitro testing and animal studies as applicable.
• Define supplier quality specifications, sampling plans, and vendor qualification.
• Assist in testing sterilization methods.
• Lead continuous improvement teams for systems and products.
• Review Engineering Change Orders.
  
  

Requirements

• Knowledge of GMP/ISO standards and quality system procedures.
• Experience with electromechanical systems and microcontroller technology.
• Understanding of risk management and analysis techniques like FMEA.
• Familiarity with regulatory compliance and working with regulatory affairs.
• Experience with design verification and validation.
• Background in engineering, quality assurance, or a related field.