What are the responsibilities and job description for the Product Development Engineer III position at Aditi Consulting?
Payrate: $50.00 - $56.00/Hour
Responsibilities Include:
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Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.
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Responsibilities Include:
- Understanding of Medical Device-New product development and Sustaining Engineering Process
- Working knowledge of technical files and Medical Device product development process
- Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process, Experience in Remediation of QMS, Tech File, DHF and Risk Management File
- Understanding of Medical regulatory standards is preferred (EU Regulations MDD & MDR)
- Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971
- Knowledge in DFMEA, PFMEA, GD&T and Design documentation processes, Experience in creation of Protocols, Testing and Verification including product usability is required
- Hardworking and should be individual in design activity and Problem-solving skills
- Should have good communication skills to be able to communicate with steak holders, project managers, outside vendors, Experience with MS Project, MS Office.
- Minimum 5 years’ experience in mechanical design, new product development of medical devices, or sustaining engineering
- Bachelor’s degree in engineering or similar engineering discipline (master’s degree in mechanical or biomedical engineering preferred)
- Experience in EUMDR product remediation is a plus
- Engineering Degree BS at least,
- Min 5 years of Med Device Experience preferred
- at least 3 years working for product development
- Understanding med device V&V process,
- Experience in EUMDR remediation PD work
- Knowledge of requirement trace to site inputs
- Drafting protocols
- Data analysis
- Test methods and test validations
- 3-4 years direct R&D experience
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.
#AditiConsulting
Salary : $50 - $56
