Cardinal Health Development Engineer in Mansfield, Massachusetts
Under the direction of the Manager of R&D, this individual will be primarily supporting maintenance of business projects (MOB) with some potential support on New Product Development (NPD) projects. This position will have emphasis on executing against all requirements of a Design History File (DHF) including creating all product development documentation, developing, and testing design requirements. The individual will be required to lead and manage all aspects of the Change Development Process (CDP) as well as work with remote teams to execute on projects. This position will act as a liaison between the Research and Development group, and Sales and Marketing, Manufacturing, Quality, Regulatory Affairs, Planning/Logistics, Packaging/Labeling and Outside Partners.
- Project and Technical Knowledge.
- Sustaining Engineering.
- Design History File (DHF) Documentation and adherence to guidelines and requirements associated with FDA/QSR design controls.
- Participate in multi-departmental teams to manage product sustaining activities.
- Create BOM’s, component/finished good specifications
- Initiate and execute Engineering Change Orders to the Quality Management System (QMS) electronic change management system
- Writing technical documents within an engineering environment, verification, validation, stability protocols, test reports and others.
- Tests developments, test set ups and execution.
- Manage assigned projects to established time lines and generate/maintain project status updates.
- Travel to Support & Drive Projects as needed.
- Education: BS in Mechanical Engineering or a related field.
- Experience: 0-3 years of experience in medical product development or related field preferred.
- Previous experience working as an engineer is a plus.
- Technical understanding of Mechanical Engineering concepts.
- Basic knowledge of Medical Devices and the design controls.
- Good communication (oral and written) and interpersonal skills.
- Proficient computer skills with Excel, Word and PowerPoint.
- Experience creating engineering documents.
- Develops solutions to well defined technical problems.
- Works effectively in a diverse group.
- Capable of developing a schedule for smaller development tasks.
- Basic knowledge of 3-D CAD systems.
- Basic knowledge of Plastics Injection Molding/Extrusion Designs.
- Basic knowledge of Design for Six Sigma (DFSS) and Design for Manufacturing and Assembly (DFMA)
- Manufacturing Experience is a plus.
- Drive for Results
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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