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EU MDR Manufacturing Engineer IV

Location: Andover, Massachusetts
Job Category:

 TOP SKILLS NEEDED: * Design Control * Remediation experience * MDR knowledge & experience * Manufacturing process experience * Project management

The EU MDR Manufacturing Engineer will 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. 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 the S&N software V&V, local design control, and change control procedures. The solution is also subject to audit by notified bodies.
2. Principal Accountabilities (Major end results the job is expected to achieve)

? 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
3. Job Context / Key Challenges

• 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
• Ability to resolve conflict in a matrix environment is a key requirement of the role.

• Establish and maintain effective relationships with third party suppliers and internal departments to ensure effective implementation of project delivery.
• To maintain and develop in-depth knowledge of the EU MDR document compliance requirements and act as the Smith & Nephew Manufacturing process expert for the subject.
• Documentation to a standard that will be accepted by internal and external auditors.
• To apply and promote high standards of Occupational Health, Safety and Environmental Compliance in accordance with the Company HSE policy and processes.
• To comply with the Ethics and Compliance Code of Conduct in all matters pertinent to Smith & Nephew.

4. Knowledge and Experience (Knowledge and experience needed for satisfactory
performance of the job)

• A science or engineering based degree, or relevant industry experience
• 4+ years of industry experience (preferably Medical Device)
• Experience of project management within a relevant industry.
• Experience/knowledge of various Manufacturing processes related to Orthopedic devices.
• Proven track record of delivery.
• Knowledge of Verification and Validation activities, PFMEAs, Macro Processing Maps, Detailed Processing Maps.
• Self- starter, with the ability to work independently
• Software programs - Microsoft Word, PowerPoint, Excel, and MS Project.
• Knowledge of applicable specification and regulations standards.
• Knowledge and understanding of documentation/quality/regulatory processes.
• Knowledge of change control processes

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