Product Development / Manufacturing Systems Engineer
Our client, in Germany are currently looking to recruit a Product Development / Manufacturing Systems Engineer for their site on a contract basis.
Purpose & Scope
- The Product Development/Manufacturing Systems Engineer is responsible for the creation of Design Transfer Documents within the Medical Devices Industry, specifically Production Requirements Specifications and Sub Assembly Specifications which align with already established Design Input Documents.
- This position will be within the R&D Department but includes interfacing with R&D, Manufacturing, Process Validation and External Suppliers.
- Reporting directly to the Project Team Lead the successful candidate will be required to produce the necessary documentation to complete Design Transfer of already designed products, including:
- Develop User Requirement Specifications and Conduct IQs for new and existing equipment.
- Conduct Capability Studies to identify optimum manufacturing conditions for production machinery.
- Conduct PFMEAs
- Create Production Requirements Specifications which detail Process Conditions required to repeatable manufacture a high quality product.
- Develop Specifications for Part Assembled Components.
Key Skills & Actions Required
- Excellent understanding of Equipment Design and Operation
- Tolerance Stack up Calculations for sub-assemblies
- Perform and lead project activities including pFMEA, DoE, SPC, etc.
- Specify Process Validation Requirements
- Creation of Documentation suitable for the Design History File and Device Master Record.
Other Tasks & Responsibilities
- Actively participate in evaluation of regulatory compliance of procedures, and processes and where necessary recommend appropriate improvements to the process.
- Organise the preparation of files suitable for FDA audit.
- Participates in and assist with facility inspections, Notified Body Audits and other audits as required.
- Identify new improvement opportunities.
- Other duties as assigned.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Education & Training & Demonstrable Skills
- A minimum of a four year college degree in engineering or science, ideally Machinenbau or Mechanical Engineering.
- Minimum of two or more years of demonstrated success in product design/design transfer or manufacturing engineering roles.
- Experience working in an ISO 13485 and/or FDA regulated medical device environment.
- Strong interpersonal communication skills and presentation skills
- Strong client centred attitude and maximum flexibility in a rapidly changing environment.
For further information on this role in Germany please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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