Medical Device Design Assurance Engineer

RadNet, Inc.; Marlborough (MA); On-site; USD 75,000 - 99,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Employee stock purchase plan

Tuition reimbursement

Life insurance

Disability insurance

Job summary

IPG Photonics in Marlborough, MA is seeking a design engineering professional to lead development and validation of Class II electro-mechanical medical devices. You will design controls, support risk management, and collaborate with regulatory teams.

This exempt role requires a Bachelor's degree in engineering, 3–5 years of relevant experience, and strong skills in Design Controls, risk management, and DOE/statistical methods using Minitab.

Qualifications

• Bachelor's degree in science or engineering (electrical preferred)
• 3–5 years of experience in engineering and development of Class II electro-mechanical medical devices
• Knowledge of Design Controls and Risk Management per FDA QSR, ISO 13485, ISO 14971, IEC 60601 etc.
• Experience with regulatory testing (EMC/EMI/IEC) with external test houses
• Maintenance of design history files and DFMEA/PFMEA; statistical methods knowledge (DOE, ANOVA) using Minitab

Responsibilities

• Conduct product design control activities for new and sustaining products
• Support risk analysis activities including DFMEA/PFMEA
• Assist with design validation/verification including software validation
• Create and maintain Design History and Technical Files
• Interact with test houses for regulatory testing (FDA/CE)
• Assist regulatory submissions to FDA, CE, and others
• Perform other duties as assigned

Skills

Class II medical devices

Design Controls

Risk Management

Regulatory standards

DOE/ANOVA

Minitab

Excel

Word

Education

Bachelor's Degree in engineering (electrical preferred)

Tools

Minitab

Microsoft Word

Excel

Job description

IPG Photonics in Marlborough, MA is seeking a design engineering professional to lead development and validation of Class II electro-mechanical medical devices. You will design controls, support risk management, and collaborate with regulatory teams.

This exempt role requires a Bachelor's degree in engineering, 3–5 years of relevant experience, and strong skills in Design Controls, risk management, and DOE/statistical methods using Minitab.