R&D Engineer – Disposable Products

Cardinal Health•Mansfield, MA

12d

About The Position

Under the direction of the Sr. Manager of Research & Development, the R&D Engineer will support Design Verification and Validation (DV&V) laboratory activities, Maintenance of Business (MOB) projects, and selected New Product Development (NPD) initiatives. This entry-level position is responsible for planning, developing, executing, and documenting engineering tests in support of medical device product development and sustaining engineering efforts. The individual will support all phases of the product lifecycle, with a primary focus on laboratory-based design verification and validation activities, Design History File (DHF) documentation, and engineering change implementation. This role will work closely with cross-functional teams including Manufacturing, Quality, Regulatory Affairs, Marketing, Packaging, Supply Chain, and external partners to ensure products meet design, performance, and regulatory requirements.

Requirements

Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline preferred.
Co-op, internship, laboratory, or project experience in product development, testing, manufacturing, or medical devices preferred.
Basic understanding of engineering principles and product development processes.
Hands-on aptitude with laboratory equipment, testing, fixtures, and data collection preferred.
Familiarity with Design Verification and Validation methodologies.
Basic knowledge of medical device design controls and regulated product development environments.
Ability to write technical documents, protocols, reports, and engineering summaries.
Experience analyzing data and developing solutions to well-defined technical problems preferred.
Ability to work effectively in cross-functional team environments.
Exposure to Design for Six Sigma (DFSS), Design for Manufacturing and Assembly (DFMA), or statistical methods is a plus.
Strong attention to detail, organizational skills, and commitment to delivering high-quality results.

Responsibilities

Develop, execute, and document design verification and validation testing activities.
Assist in the design, setup, operation, and maintenance of laboratory test equipment and fixtures.
Create test methods, test methods validations, protocols, reports, and data summaries in accordance with applicable procedures and standards.
Perform hands-on testing of products, components, and assemblies to evaluate performance, reliability, and compliance with design requirements.
Collect, analyze, and communicate test results and observations to project teams.
Support Maintenance of Business (MOB) and New Product Development (NPD) projects as a contributing member of cross-functional teams.
Participate in engineering evaluations, product improvements, and sustaining engineering activities.
Develop engineering documentation including specifications, protocols, reports, risk assessments, and technical summaries.
Create and maintain Bills of Material (BOMs), component specifications, and finished good specifications.
Support engineering change implementation through the Quality Management System (QMS).
Support the development and maintenance of Design History File (DHF) documentation.
Ensure compliance with FDA Quality System Regulations (QSR), design control requirements, and internal procedures.
Assist in generating verification, validation, stability, and technical documentation required for product development activities.
Maintain accurate records of test activities and project documentation.
Manage assigned tasks and small projects to established timelines.
Provide regular status updates and communicate project risks or issues.
Collaborate effectively with internal and external stakeholders to achieve project objectives.