Product Development Engineer / Design Quality Engi (1146579)

The Judge Group; Marlborough (MA); On-site; USD 85,000 - 100,000; Full time

Job summary

The Judge Group is seeking a Product Development Engineer / Design Quality Engineer in Marlborough, MA. You will lead design control activities for new product development and sustaining projects in a FDA-regulated medical device environment.

You will support risk management (DFMEA/PFMEA), participate in design/ process verification and validation (DV/ PV/ IQ/OQ/PQ), and help maintain DHFs, technical files, and design specifications. 3–5 years experience required.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• Electrical Engineering degree preferred.
• 3–5 years of experience in the design and development of Class II electro-mechanical medical devices.
• Experience in FDA-regulated and ISO-compliant medical device environments.

Responsibilities

• Conduct product design control activities for both new product development and sustaining engineering projects.
• Support risk management activities, including DFMEA and PFMEA.
• Participate in design and process verification/validation activities (DV, PV, Software Validation, IQ/OQ/PQ).
• Support Design Engineering in the development and maintenance of DHF, Technical Files, design specifications, and verification/validation documentation.

Skills

Design control

Risk management

Quality engineering

Regulatory compliance

Education

Bachelor's degree in engineering/related field

Electrical Engineering degree preferred

Tools

DFMEA

PFMEA

DV/PV/IQOQPQ

DHF/Technical Files

Job description

Location: Marlborough, MA

Salary: $85,000.00 USD Annually - $100,000.00 USD Annually

Description: Our client is currently seeking a Product Development Engineer / Design Quality Engineer.

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.
• 3 to 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.