Principal Medical Device R&D Leader

cardinalhealth; Mansfield (MA); On-site; USD 108,000 - 154,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage (short- and long-)

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Mansfield, MA, is seeking a Principal Research & Development Engineer to drive the design, development, verification, validation, and lifecycle management of medical device products, ensuring compliance with design controls and regulatory standards.

You will lead cross-functional efforts across Quality, Regulatory, Manufacturing, Clinical, Human Factors, Marketing, and suppliers, mentoring teams, guiding technical strategy, and ensuring robust risk management throughout the

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering or related field.
• Experience with medical device design controls and risk management.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Lead new product development and sustaining engineering programs for Medical Devices.
• Incorporate regulatory standards (FDA, ISO, IEC, EN) into design strategies.
• Provide technical leadership for 510(k) submissions and design reviews.

Skills

Biomedical Engineering

Mechanical Engineering

Regulatory knowledge

Project management

CAD

Six Sigma (DFSS)

Education

Bachelor's Degree in Biomedical or Mechanical Engineering

Tools

SolidWorks

Microsoft Project

Job description

Cardinal Health in Mansfield, MA, is seeking a Principal Research & Development Engineer to drive the design, development, verification, validation, and lifecycle management of medical device products, ensuring compliance with design controls and regulatory standards.

You will lead cross-functional efforts across Quality, Regulatory, Manufacturing, Clinical, Human Factors, Marketing, and suppliers, mentoring teams, guiding technical strategy, and ensuring robust risk management throughout the