Remote Design Quality Engineer, Medical Devices

Getinge; Waltham (MA); Hybrid; USD 100,000 - 110,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge in Waltham, MA is seeking a Design Quality Engineer to ensure medical device design controls, risk management, and regulatory compliance across development projects. The role collaborates with R&D, manufacturing, regulatory affairs, and quality assurance to drive design control excellence.

You will implement design control processes in line with ISO 13485, ISO 14971, FDA QSR, and MDR; lead risk assessments; and drive continuous improvement while traveling up to 10% for supplier and

Qualifications

• Bachelor's degree in engineering or related field; advanced degree preferred.
• 1–3 years in quality engineering within medical devices.
• Strong knowledge of design control, risk management, ISO 13485, ISO 14971, FDA QSR.

Responsibilities

• Implement and maintain design control processes per regulatory standards.
• Lead risk management activities across the design process.
• Develop and execute quality plans for new product development.
• Review design inputs and validate design outputs.
• Manage design changes and approvals.
• Develop verification and validation protocols and collaborate with testing teams.
• Collaborate across functions to ensure compliance and process improvements.
• Support regulatory submissions as needed.

Skills

Design Control

Risk Management

Quality Systems

FDA QSR

Six Sigma / DMAIC

Regulatory Knowledge

Education

Bachelor's in Engineering

Tools

Minitab

JMP

Excel

Job description

Getinge in Waltham, MA is seeking a Design Quality Engineer to ensure medical device design controls, risk management, and regulatory compliance across development projects. The role collaborates with R&D, manufacturing, regulatory affairs, and quality assurance to drive design control excellence.

You will implement design control processes in line with ISO 13485, ISO 14971, FDA QSR, and MDR; lead risk assessments; and drive continuous improvement while traveling up to 10% for supplier and