Director, Design Assurance - Medical Devices & Software

Nova Biomedical; Waltham (MA); Hybrid; USD 175,000 - 240,000; Full time

Benefits offered by this job

Hybrid work arrangements

401k match

Bonus program

Generous PTO and holidays

Office marketplace for lunch and snack

Job summary

Nova Biomedical in Massachusetts seeks a Director, Design Assurance to lead global design controls and quality systems for medical devices, ensuring compliance with FDA QMSR, ISO standards, and regulatory requirements.

The role partners with R&D, Regulatory Affairs, Manufacturing, and others to support product development, design transfer, and lifecycle management, including design reviews and governance across software-enabled devices.

Qualifications

• Bachelor's degree in a technical field required; advanced degree preferred.
• Minimum 15 years in medical device/regulated healthcare.
• Minimum 10 years of progressive leadership in quality/design assurance.
• Experience supporting FDA inspections and international audits.
• Experience with Class II medical devices and product lifecycle management.
• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, ISO 9001, IVDR, MDSAP.

Responsibilities

• Lead and continuously improve global Design Assurance for new product development and lifecycle management.
• Establish and maintain design control processes, including planning, inputs/outputs, reviews, verification, validation, and changes.
• Integrate risk management across product lifecycle per ISO 14971.
• Provide leadership to ensure compliance and meet customer quality expectations.
• Govern Design and Development Files with traceability and audit readiness.
• Oversee software lifecycle quality, cybersecurity considerations, and evidence.

Skills

Leadership

Quality systems

Regulatory affairs

Cross-functional collaboration

Risk management

Education

Bachelor's degree in Engineering/QA/Regulatory Affairs

Tools

QMS software

Document control systems

Job description

Nova Biomedical in Massachusetts seeks a Director, Design Assurance to lead global design controls and quality systems for medical devices, ensuring compliance with FDA QMSR, ISO standards, and regulatory requirements.

The role partners with R&D, Regulatory Affairs, Manufacturing, and others to support product development, design transfer, and lifecycle management, including design reviews and governance across software-enabled devices.