Product Development Engineer III

Industry: pharmaceutical, biotechnology

Duration: 7 Months (40hrs/weeks)

Responsibilities:

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 Mechanical Engineering or similar engineering discipline (Master’s degree in mechanical or biomedical engineering preferred),

Experience in EUMDR product remediation is a plus

Nice to have Skills :

4. Experience in EUMDR remediation PD work

Must Have Skill :

1. Mech Engineering Degree BS at least,

2. Min 5 years of Med Device Experience working for product development,

3. Understanding med device V&V process,

Shift:

1st shift, day M-F