What are the responsibilities and job description for the Product Development Engineer III (Medical Devices) position at Not applicable1?
Job Title: Product Development Engineer III
Work Site/Location: This will be remote.
on-site in Mansfield, MA is a bonus
Work Schedule: 9-5pm – 8 hours a day.
Must Have Skill :
1. Engineering Degree BS at least,
2. Min 5 years of Med Device Experience preferred
3. at least 3 years working for product development
3. Understanding med device V&V process,
Nice to have Skills :
4. Experience in EUMDR remediation PD work
knowledge of requirement trace to site inputs
drafting protocols
data analysis
test methods
test validations
3-4 years direct R&D experience
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. Qualifications include: Experience: minimum 5 years experience in mechanical design, new product development of medical devices, or sustaining engineering, Education: 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
