Medical Device Product Dev & Design Quality Eng

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

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.