Strategic Lead, Medical Device R&D

Cardinal Health; Robinsonville (MA); On-site; USD 108,000 - 154,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid time off

Health Savings Account (HSA)

401k savings plan

myFlexPay for early wage access

Job summary

Cardinal Health is seeking a Principal Research & Development Engineer to lead the design, development, verification, validation, and lifecycle management of medical device products. The role provides strategic technical leadership across all phases of product development, ensuring compliance with design controls, regulatory standards, and quality systems.

In a highly cross-functional environment, you will guide projects, mentor engineers, and drive continuous improvement while collaborating

Qualifications

• Bachelors degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 4+ years of relevant medical device experience.
• Knowledge of medical device design controls and stage-gate development process.
• Experience with CAD, preferably SolidWorks.
• Manufacturing and patent experience is a plus.
• Experience with Microsoft Project.
• DFSS certification preferred.
• Proven PM experience in product development.

Responsibilities

• Lead new product development, enhancements, and sustaining engineering programs for medical devices.
• Develop design strategies and ensure compliance with FDA, ISO, IEC, EN standards.
• Support 510(k) submissions and regulatory requirements.
• Create and review technical specifications, protocols, and reports for verifications and validations.
• Perform design reviews and manage change through the development lifecycle.
• Coordinate product transfers from R&D to manufacturing.
• Travel as needed to support projects.

Skills

Project management

Design controls knowledge

Risk management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelors or higher in Biomedical/Mechanical Engineering or related field

Tools

SolidWorks

Microsoft Project

Job description

Cardinal Health is seeking a Principal Research & Development Engineer to lead the design, development, verification, validation, and lifecycle management of medical device products. The role provides strategic technical leadership across all phases of product development, ensuring compliance with design controls, regulatory standards, and quality systems.

In a highly cross-functional environment, you will guide projects, mentor engineers, and drive continuous improvement while collaborating