Principal Medical Device R&D Engineer

Cardinal Health, Inc.; Mansfield (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 access

FSAs

Disability coverage

Job summary

Cardinal Health, Inc. is seeking a Principal Research & Development Engineer to lead medical device product design, development, verification, validation, commercialization, and lifecycle management with a focus on design controls and regulatory standards.

The role requires strategic leadership across all phases of product development, collaboration with QA, Regulatory Affairs, Manufacturing, Clinical, Human Factors, and external partners to deliver safe, innovative healthcare solutions and to

Qualifications

• Bachelor’s Degree or higher in Biomedical Engineering, Mechanical Engineering, or related field preferred.
• 4+ years of relevant medical device experience preferred.
• Proven track record of successful technical project management in a product development environment preferred.
• Knowledge of medical device design controls, stage gate product development process preferred.
• Knowledge of mechanical systems, plastics Injection Molding and component designs preferred.
• Experience with CAD, preferably SolidWorks is a plus.
• Manufacturing and Patent Experience is a plus.
• Experience with Microsoft Project preferred.

Responsibilities

• Lead new product development, product enhancements, and sustaining engineering programs of Medical Devices.
• Develop and execute design strategies effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN).
• This position will work on complex projects of large scope and will provide technical leadership for Medical Device 510k submissions for new products.
• Contribute to the development of policies and procedures.
• Write and review technical specifications.
• Conduct technical and design reviews.
• Write protocols and reports for various technical aspects including design verifications and validations.
• Conduct and/or orchestrate Finished device and or part level testing.
• Conduct product development tasks & documentation required to satisfy design controls (Design History) and risk management following established SOPs.
• Provide presentations, reports and schedules required to manage projects and to communicate status, risks and issues.
• Provide solutions to technical issues and implement using the established Change Development Process.
• The ability to work with a diverse team in various locations in the US, Asia and other locations will be required.
• Product transfer from R&D to manufacturing.
• Travel to support and Drive Projects as needed.

Skills

Project management

Design controls

Risk management

Cross-functional collaboration

Design for Six Sigma

Education

Bachelor's in Biomedical/Mechanical Engineering

Tools

SolidWorks

Microsoft Project

Job description

Cardinal Health, Inc. is seeking a Principal Research & Development Engineer to lead medical device product design, development, verification, validation, commercialization, and lifecycle management with a focus on design controls and regulatory standards.

The role requires strategic leadership across all phases of product development, collaboration with QA, Regulatory Affairs, Manufacturing, Clinical, Human Factors, and external partners to deliver safe, innovative healthcare solutions and to