Great company is looking for Manufacturing Engineer with Medical Device experience to perform review/remediation Design Control activities involved in the technical filing of product, under supervision of the EU MDR Engineering Systems Manager. This position will support the EU MDR department by performing tasks that will assure the timely delivery of the documentation, working with cross functional departments.
Remote Work and 12+ month contract
location: Cordova, Tennessee
job type: Contract
salary: $35 - 45 per hour
work hours: 9am to 5pm
- The EU MDR Manufacturing Engineer will This role will be responsible for the delivery of tasks to ensure conformance to the project plan schedule and for ensuring efficient and effective communication of affected technical file documents for manufacturing to support EU MDR submissions. The SCOPE covers product in the Memphis Orthopedics groups. This covers all manufacturing sites (including 3rd parties) and must be implemented in line with the relevant MDR timelines in order to continue to sell product in Europe. All projects are to be managed using local design control, and change control procedures.
- To take ownership of the manufacturing engineering tech document process, ensure it is adhered to and applied effectively, correctly and efficiently
- Effectively manage 3rd party suppliers (with support of Procurement and Supplier Quality) to deliver expected outcomes (50+ 3rd parties in 5 continents)
- To deliver the deliverables for MDR Manufacturing prior to MDR timelines associated with the project
- To take responsibility that change control procedures are followed and that the quality of the work is acceptable to internal and external auditors eg group audit, BSI and FDA
- Strong communication skills including technical writing, listening and speaking; ability to influence others communicate effectively with multi-functional teams (internal and external) that assists with driving project completion.
- High learning agility with the ability to analyse and synthesize data and then present it to senior leaders
- Independent thinking and the ability to work within a team is required
- Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving
- A science or engineering based degree, or relevant industry experience
- Experience of project management within a relevant industry.
- Experience/knowledge of various Manufacturing processes related to Orthopedic devices.
- Knowledge of Verification and Validation activities, PFMEAs, Macro Processing Maps, Detailed Processing Maps.
- Self- starter, with the ability to work independently
- Knowledge of applicable specification and regulations standards.
- Knowledge and understanding of documentation/quality/regulatory processes.
- Knowledge of change control processes
- Medical Device, manufacturing engineer, processes, Verification and Validation, PFMEAs, Macro Processing Maps, Detailed Processing Maps.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.