Senior Medical Device R&D Architect

Cardinal Health, Inc.; Robinsonville (MA); Presencial; USD 108.000 - 154.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision

401k

HSA

Paid time off

Flexible spending accounts

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Descripción de la vacante

Cardinal Health, Inc. seeks a Principal Research & Development Engineer in Massachusetts to lead design, verification, validation, and lifecycle management of medical device products.

This role ensures design controls, regulatory standards, and quality systems are adhered to across development phases. The incumbent will mentor teams, collaborate with Quality Assurance, Regulatory, Manufacturing, Clinical Affairs, Human Factors, Marketing and suppliers, and influence technical strategy to deliver

Formación

• Strong project management skills and experience in medical device development.
• Familiar with design controls and regulatory standards.
• Experience with CAD software and change management processes.

Responsabilidades

• Lead new product development and sustaining engineering programs for medical devices.
• Develop and implement design strategies compliant with FDA/ISO/IEC standards.
• Provide technical leadership for 510(k) submissions.
• Write and review technical specifications and design verifications/validations.
• Mentor engineering teams and drive cross-functional collaboration.
• Manage project schedules, risks, and communications with stakeholders.
• Support product transfer from R&D to manufacturing and participate in APC decisions.
• Travel as needed to support projects.

Conocimientos

Project management

Cross-functional collaboration

Problem solving

Educación

Bachelor’s Degree in Biomedical/Mechanical Engineering

DFSS certification

Herramientas

SolidWorks

Microsoft Project

Descripción del empleo

Cardinal Health, Inc. seeks a Principal Research & Development Engineer in Massachusetts to lead design, verification, validation, and lifecycle management of medical device products.

This role ensures design controls, regulatory standards, and quality systems are adhered to across development phases. The incumbent will mentor teams, collaborate with Quality Assurance, Regulatory, Manufacturing, Clinical Affairs, Human Factors, Marketing and suppliers, and influence technical strategy to deliver