Principal Medical Device R&D Engineer

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

HSA and FSAs

Job summary

Cardinal Health is seeking a Principal R&D Engineer to lead design, development, verification and lifecycle management of medical device products. You will drive cross-functional projects, ensure regulatory compliance (FDA, ISO, IEC, EN) and mentor engineering teams across locations in the US and abroad.

The role includes design transfers to manufacturing and 510(k) submissions. Ideal candidates have a Biomedical or Mechanical Engineering background, DFSS certification, 4+ years of medical

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering or related field.
• DFSS certification is preferred.
• 4+ years of medical device experience is preferred.
• Proven track record of technical project management in product development.
• Knowledge of medical device design controls and stage-gate processes.
• Knowledge of mechanical systems, plastics injection molding and component designs.
• Experience with CAD, preferably SolidWorks.
• Manufacturing and patent experience is a plus.
• Experience with Microsoft Project preferred.

Responsibilities

• Lead new product development, enhancements and sustaining engineering for medical devices.
• Develop and execute design strategies satisfying regulatory standards (FDA, ISO, IEC, EN).
• Provide technical leadership for 510(k) submissions and product transfers to manufacturing.
• Produce design plans, specifications, reviews, tests and reports.
• Conduct verification, validation and risk management per SOPs and design controls.
• Collaborate across QA, Regulatory, Manufacturing, Clinical, HR and external partners.
• Mentor engineering teams and drive continuous improvement initiatives.

Skills

Project management

Risk management

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Design for Six Sigma (DFSS) certification

Tools

SolidWorks

Microsoft Project

Job description

Cardinal Health is seeking a Principal R&D Engineer to lead design, development, verification and lifecycle management of medical device products. You will drive cross-functional projects, ensure regulatory compliance (FDA, ISO, IEC, EN) and mentor engineering teams across locations in the US and abroad.

The role includes design transfers to manufacturing and 510(k) submissions. Ideal candidates have a Biomedical or Mechanical Engineering background, DFSS certification, 4+ years of medical