ProClinical has an exciting opportunity for a Product Development/Manufacturing Systems Engineer who will be 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.
- 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).
- 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.
Skills and Requirements:
- 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
- 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 centered attitude and maximum flexibility in a rapidly changing environment.
- Lean Six-Sigma experience - ideally Green Belt or Black Belt accreditation.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 203 0789 554 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.