SUMMARY OF POSITION:
A Principal Research and Development Engineer for Electro-mechanical Group will perform design and development as well as product sustaining engineering activities. These activities will cover all phases of the product life cycle from concept through end of life. The individual in this position will often lead small projects, but will also assume an individual contributor role. The engineer must have the flexibility of skill and temperament to work in both product development, and product change development. Attention to detail and working knowledge of regulations for the medical device industry are essential. The engineer must be able to work in a team environment and be able to communicate clearly across all disciplines including Quality Assurance, Regulatory Affairs, Manufacturing, Marketing and outside design partners and regulatory agencies.
ESSENTIAL FUNCTIONS AND ACCOUNTABILTIES:
- Contribute to the development and maintenance of Medical Devices.
- 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 device and component testing
- Conduct product development tasks & documentation required to satisfy design controls and risk management in accordance with established SOPs.
- Provide presentations, reports and schedules as required to manage projects and to communicate status, risks and issues.
- Effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN)
- Construct Design History Files in accordance with SOP’s.
- Provide solutions to technical issues and implement using the established Change Development Process
- Work directly with offsite and 3rd party design engineering resources
- May act as mentor to less experienced colleagues
- Product transfer from R&D to manufacturing
- Travel to support and Drive Projects
Education: BS, Biomedical Engineering or BS, Mechanical Engineering preferred
Bachelor’s plus a minimum of 6+ years relevant medical device experience; or Master’s plus a minimum of 4 years relevant medical experience preferred
- Knowledge of Medical Device design controls and Stage Gate product development process
- Self Driven/Motivated & Strong Background in Multitasking
- Intermediate Time Management and Prioritization skills
- Strong written, verbal, and presentation skills
- Experience with Plastics Injection Molding Designs
- Experience with CAD preferably Solidworks
- MS office tools including Word, Excel, PowerPoint, Project
- Familiarity with electrical and medical device safety standards
- Thorough understanding of engineering practices, product safety and root cause analysis.
- Design for Six Sigma (DFSS) trained and certified is a plus
- Manufacturing and Patent Experience is a plus
- Familiarity with manufacturing processes utilized in durable medical equipment production
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.