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 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 repeatedly manufacture a high-quality product.
- Develop Specifications for Part Assembled Components.
- 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.
Skills and Requirements:
- 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.
- 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.
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.