Senior Medical Device Engineer: Quality & Compliance

ClinLab Solutions Group; Billerica (MA); Presencial; USD 95.000 - 120.000; Jornada completa

Descripción de la vacante

ClinLab Solutions Group in Middlesex County, Massachusetts, is seeking a mechanical/electromechanical engineer to support current and new medical device projects, ensuring product quality, compliance, and continuous improvement.

You will investigate product issues, develop design controls, generate documentation, conduct mechanical testing, and support regulatory submissions while mentoring technicians and collaborating with suppliers.

Formación

• BS in Mechanical Engineering required; an Associate’s degree or relevant experience will be considered.
• 7 years of experience in the medical device industry.
• Ability to interpret and resolve technical/design issues.
• Familiarity with QSR/GMP regulations.
• Experience with SolidWorks and Microsoft Office Tools.

Responsabilidades

• Support existing medical products by investigating issues, identifying root causes, and implementing solutions.
• Prepare and maintain product documentation, including specs, BOMs, hazard analyses, test procedures, and validations.
• Conduct mechanical tests to ensure designs meet standards, safety margins, and reliability.
• Participate in project teams, assisting with planning, estimation, scheduling, tracking, and reporting.
• Develop design controls, risk assessments, and related documentation per regulatory requirements.
• Provide training or direction to technicians, manufacturing staff, or suppliers.

Conocimientos

Root cause analysis

Technical issue resolution

Design interpretation

Educación

BS in Mechanical Engineering

Associate’s degree in Mechanical Engineering or relevant experience

Herramientas

SolidWorks

Microsoft Office

Descripción del empleo

ClinLab Solutions Group in Middlesex County, Massachusetts, is seeking a mechanical/electromechanical engineer to support current and new medical device projects, ensuring product quality, compliance, and continuous improvement.

You will investigate product issues, develop design controls, generate documentation, conduct mechanical testing, and support regulatory submissions while mentoring technicians and collaborating with suppliers.