Senior Product Development / Manufacturing Systems Engineer
Our client, a medical device company in Germany are currently looking to recruit a Senior Product Development / Manufacturing Systems Engineer for their site on a contract basis.
Purpose & Scope
- The Senior Product Development/Manufacturing Systems Engineer is responsible for the creation of Design Transfer Documents within the Medical Devices Industry, specifically Material Component 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 have the responsibility for leading a team of 4 engineers to produce the necessary documentation to complete Design Transfer of already designed products, including:
- Develop Component Specifications and Associated First Article Inspection Plans for all Purchased Components
- Develop Material Specifications for Manufacturing Materials.
- Develop Specifications for Part Assembled Components.
- Develop Specifications for all in-house and externally produced labels (excluding artwork).
Key Skills & Actions Required
- Develop Component tolerances in agreement with R&D and Suppliers
- Tolerance Stack up Calculations for sub-assemblies
- Perform and lead project activities including dFMEA, pFMEA, DoE, SPC, etc.
- Specify Process Validation Requirements
- Test Method Development
- 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.
- Participate in and lead internal audits.
- 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.
- A minimum of a four year college degree in engineering or science.
- Minimum of five or more years of demonstrated success in product design and development engineering roles with increasing responsibility in an ISO 13485 and/or FDA regulated medical device product development environment, with the following demonstrable success:
- Demonstrable success in transferring new product development projects from design to manufacturing and to external suppliers.
- Strong interpersonal communication skills and presentation skills
- Strong client centred attitude and maximum flexibility in a rapidly changing environment.
- Lean Six-Sigma experience - ideally Green Belt or Black Belt accreditation.
For further information on this role in Germany please contact Bimi Felix on 091730022 / email@example.com
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