Principal R&D Engineer

Cardinal Health•Mansfield, MA

6d•$107,900 - $154,100

About The Position

The Principal Research & Development Engineer is a technical leader responsible for the design, development, verification, validation, commercialization, and lifecycle management of medical device products. This role provides strategic and technical leadership across all phases of product development, ensuring compliance with design control requirements, regulatory standards, quality systems, and engineering best practices. The Principal R&D Engineer leads complex product development and sustaining engineering initiatives while serving as a subject matter expert in product design, risk management, verification and validation, and change management. Working in a highly cross-functional environment, the engineer collaborates with Quality Assurance, Regulatory Affairs, Manufacturing, Clinical Affairs, Human Factors, Marketing, suppliers, and external partners to deliver safe, effective, and innovative healthcare solutions. In addition to project leadership, the Principal R&D Engineer drives continuous improvement efforts, supports technical problem-solving and root cause investigations, and mentors engineering teams. The individual is expected to influence technical strategy, guide critical business decisions, and ensure products consistently meet customer needs, intended use requirements, and regulatory expectations throughout the product lifecycle.

Requirements

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.

Nice To Haves

Design for Six Sigma (DFSS)

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).
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 Fished 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. This will include Quality, Regulatory, Manufacturing, and other technical groups such as 3rd party design engineering resources.
Product transfer from R&D to manufacturing.
Travel to support and Drive Projects as needed.