Location : Upper Saddle River NJ US 07458
Job Type : Temp/Contract
Reference Code : 20410-BZ1
Compensation : open - 35-45/h
Start Date : 01/12/2021
Hours : Full Time
Required Years of Experience : 1-2
Required Education : BS Mechanical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Mechanical Engineer for EU MDRpProject support creating Technical Documents for medical devices.
- Products will include implantable devices and instruments.
- Position is part of an R&D team focused on EUMDR compliance.
- Review and create the Technical Files as part of the EUMDR team.
- Review existing DHFs and translate the specifications related to design, verification, validation and standards into the new Technical Files.
- Use CAD (Pro/ENGINEER) to modify drawings as part of Change Control to meet changes such as identification and design updates.
- Use of mechanical engineering knowledge/skills to interpret design history file (DHF) documents with expertise in medical device.
- Use mechanical engineering knowledge and technical writing for creation of Engineering Analysis documents.
- Support for product testing within the internal lab as needed.
- All work will be done using Teams/Sharepoint style collaboration sites.
Required Qualifications :
- BS Mechanical Engineering
- Minimum 1-2 years experience with medical device design.
- Experience with Pro/ENGNIEER.
- Attention to detail and application of sound engineering practices to ensure compliance of files to meet the EUMDR compliance standards.
- Experience with DHFs and Change Controls.
Contact: Bill Zukowsky