- Expired: over a month ago. Applications are no longer accepted.
Mechanical Engineer- Long Term contract opportunity- May go full time.
Position is critical to the UKCA (United Kingdom medical device regulatory) project. This role is part of the R&D Workstream, for the overall Division project. The person will be part of an existing R&D team, and work with the multiple cross functions to ensure alignment and On Time completion. Person must be team orientated, able to work on focused assignments, and strong communication skills. Technical report writing is required. Job is Hybrid from a location perspective, with a primary location being remote, with potential on site based on project needs and company guidance.
- UKCA Project support for creation of Tech Docs for medical devices.
- The products will include implantable devices and instruments.
- This position will be part of an R&D team focused on Britain's compliance.
- This engineering position will review and create the Technical Files for the company as part of the cross functional team.
- The engineer will review existing DHFs and translate the specifications related to design, verification, validation and standards into the new Tech Files.
- Ability to use CAD (PROe 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 documents with expertise in medical device (preferred).
- Using mechanical engineering knowledge and technical writing, creation of Engineering Analysis documents.
- All work will be done using Teams/SharePoint style collaboration sites.
- Attention to detail and application of sound engineering practices to ensure compliance of files to meet the EUMDR compliance standards.
Global Medical Device Manufacturing Company
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