Visionary Medical Device R&D Engineer

Cardinal Health; United States; On-site; USD 108,000 - 154,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k plan

Job summary

Cardinal Health seeks an experienced Principal Research & Development Engineer to lead medical device product development, verification, validation, and lifecycle management. You will work across QA, Regulatory, Manufacturing, Clinical, Human Factors, and Marketing to ensure safe, effective solutions.

You will guide design strategies, risk management, and change processes, while mentoring teams and influencing technical direction for lifecycle success across locations in the US and abroad.

Qualifications

• Bachelor’s degree or higher in Biomedical or Mechanical Engineering or related field.
• Design for Six Sigma (DFSS) certification preferred.

Responsibilities

• Lead new product development, enhancements, and sustaining engineering for medical devices.
• Incorporate regulatory standards (FDA/ISO/IEC) into design strategies.
• Lead complex projects and contribute to 510(k) submissions for new products.
• Develop and review design verifications/validations and risk management activities.
• Mentor engineering teams and drive cross-functional collaboration across QA, Regulatory, Manufacturing, and Marketing.

Skills

Technical leadership

Product development

Regulatory knowledge

Cross-functional collaboration

Risk management

Verification & validation

Change management

Education

Bachelor’s degree in Biomedical/Mechanical Engineering or related field

Design for Six Sigma (DFSS) certification

Tools

SolidWorks

CAD software

Microsoft Project

Job description

Cardinal Health seeks an experienced Principal Research & Development Engineer to lead medical device product development, verification, validation, and lifecycle management. You will work across QA, Regulatory, Manufacturing, Clinical, Human Factors, and Marketing to ensure safe, effective solutions.

You will guide design strategies, risk management, and change processes, while mentoring teams and influencing technical direction for lifecycle success across locations in the US and abroad.