Design Assurance Engineer

G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing); Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Our Marlboro, MA client is seeking a Design Assurance Engineer to lead design control activities for new and sustaining medical devices, in a direct-hire role.

Responsibilities include risk analysis with FMEA, design verification/validation including IQ/OQ/PQ, and creation of DHF/technical files; requires a Bachelor's in engineering or science and 3–5 years' experience with Class II electromechanical devices.

Qualifications

• Bachelor's degree in engineering or science field.
• 3–5 years of experience with Class II electro-mechanical medical devices.
• Knowledge of design controls and risk management practices.

Responsibilities

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.

Skills

Design Controls

Risk Management

Software Validation

Education

Bachelor's Degree in scientific or engineering field

Tools

DHF management

Regulatory Standards knowledge

Job description

Our client in Marlboro, MA is looking for a Design Assurance Engineer. This is a direct hire opportunity.

Responsibilities

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.

Experience

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred
• 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices.
• Knowledge of Design Controls and Risk Management practices, regulations and standards.
• Knowledge of Quality Design and validations.