Senior Medical Device R&D Engineer – Test Strategy & Validation

Gentuity, LLC.; Sudbury (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Gentuity, LLC. is seeking a skilled professional to develop and lead design verification and validation (V&V) strategies for medical devices. This role entails ensuring compliance with regulatory standards, overseeing the execution of test activities, and maintaining documentation integrity.

The ideal candidate will have over 10 years of experience in medical device development, particularly with Class II devices, and demonstrate strong leadership in cross-functional collaboration.

Qualifications

• 10+ years of experience in medical device development and testing.
• Proven experience with Class II medical devices regulated under FDA.
• Hands-on experience with electromechanical, optical, or fluidic systems.

Responsibilities

• Develop and lead V&V plans compliant with regulatory requirements.
• Execute design verification and validation activities.
• Oversee test data analysis and documentation.

Skills

Test protocol development

Collaboration

Risk management

Data analysis

Regulatory compliance

Education

Bachelor’s or Master’s in Biomedical Engineering

Tools

Minitab

MATLAB

Job description

Gentuity, LLC. is seeking a skilled professional to develop and lead design verification and validation (V&V) strategies for medical devices. This role entails ensuring compliance with regulatory standards, overseeing the execution of test activities, and maintaining documentation integrity.

The ideal candidate will have over 10 years of experience in medical device development, particularly with Class II devices, and demonstrate strong leadership in cross-functional collaboration.