Senior Manufacturing Engineer

Our client a high potential medical device start up are currently recruiting for a Senior Manufacturing Engineer to join their team. The Senior Manufacturing Engineer will be responsible for the ongoing manufacturing process development of a new cleanroom based product manufacture in accordance with international standards and best practices. The Senior Manufacturing Engineer will work closely with the R&D and Quality teams and will improve manufacturing processes, support market submissions and external audits by FDA, Notified Body, other agencies and vendors during company audits/inspections.



Role/Responsibilities

• Develop and manage the manufacturing and QC processes

in collaboration with the R&D Team.

• Support design/development change control activities in accordance with all applicable SOPs.

Assure the content of DHF documents meet regulatory and company requirements.

• Partner with R&D and Quality to ensure that the transition of products through R&D, product

approval and manufacturing scale up are smooth, timely and cost effective.

• Draft IQ/OQ/PQ protocols and reports for new equipment. Develop and execute required

validations in line with regulatory requirements to include Equipment, Process & Product

validations.

• Manage Preventive Maintenance and Calibration routines. Manage tooling, equipment and

consumable spare parts inventory to support manufacturing capacity.

• Manage Cleanroom monitoring, cleaning and certification activities.

• As part of the technical team, establish and maintain appropriate Manufacturing

documentation including, SOPs, WIs, Equipment documentation and logs, DHRs, risk

management (pFMEAs), Bills of Materials, Part Numbers, Product routings.

• Manufacturing support of product verification and validation activities.

• Operator recruitment, training & management.

• Set up and order Product, Components, Consumables, and Material necessary for validation

and production (stock management including incoming inspection).

• Management and segregation of non-conforming product and non-sterile product.

• Supports inspections and audits by external bodies.

• Management of suppliers supporting manufacturing equipment, cleanroom and facility.

• Ensure that accurate and complete records of department activities are kept, and that they

meet regulatory requirements.

• Provide leadership direction to team on problem solving and process improvements, address

obstacles, provide resources and interact with other areas of the company to assist team in

implementing process and compliance improvements and streamlining the work process.

• Maintain and improve health & safety systems and promote EHS compliant culture.



Skills/Experience

• Recommend 5 years' post-qualification experience within a Medical Device manufacturing

environment.

• Operations and / or Process Development experience would be beneficial.

• Experience with QMS systems applicable to medical devices (primarily 21 CFR 820 and ISO

13485).

• Strong technical understanding of set-up and maintenance of manufacturing processes.

• Experience in validation, equipment design and Lean Manufacturing highly desirable.

• Equipment Procurement and Validation experience.

• Risk Management (FMEA) experience desirable.

• Experience conducting IQ/OQ/PQ's and/or validations previously in a regulated environment.

• Flexibility to travel to manufacturing sites and pre-clinical / clinical trial locations to support

project activities.

• Strong interpersonal and organizational skills and the ability to work effectively as a team

member.



For further information please contact James Cassidy [email protected] or call in confidence 0860204322