The main responsibilities of the role are;

• Primarily accountable for the validation and validation maintenance of manufacturing processes, and test methods, manufacturing equipment and facilities.
• Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives
• Perform validation of processes, equipment and facilities used in manufacture of medical devices to meet Regulatory requirements, this incorporates completion of validation protocol, installation qualification, operational qualification and performance qualification and supporting documentation
• Prepare and issue Validation Master Plans and schedules, summary reports and other required documentation for a validation exercise
• Organize and execute validation activities in order to provide an effective validation service
• Provide validation expertise to ensure that all operations are carried out in compliance with regulatory and company requirements
• Provide validation support and advice to other areas of the business as required
• Ensure projects relating to processes, facilities and equipment, are validated in line with regulatory and company requirements
• Provide specialist knowledge on process, facility, equipment issues within the site
• Promote effective working relationships and ensure they are maintained through the validation working party
• Support a continuous improvement culture within the business
• Provide guidance, and direction to staff consistent with appropriate standards
• Develop work plans, assign tasks, and supervise teams as appropriate
• Ensure staff have appropriate knowledge and training on department and site, processes and procedures
• Address site validation gaps via generation and completion of Validation Master Plans and schedules
• Maintain site validation status according to regulatory requirements

The successful candidate will possess;

• Degree qualified with validation experience from within a scientific regulated environment
• A good working knowledge of appropriate Standards and Regulations
• Experience in direct investigation/troubleshooting of validation problems
• Experience in Analytical Test Method Validation
• Experience in Equipment Qualification Good statistical knowledge (DOE, capability studies, Gauge R&R, sample size definition, etc)
• Experience in the areas of qualification, analytical methods, lab equipment qualification, computer system validation, and requalification
• Proficiency in Minitab and Microsoft packages

You will play a key part in the full product lifecycle—from early concept evaluation through to verification, documentation and transfer to manufacturing—working closely with Engineering, Quality, Manufacturing, Clinical Services, Marketing, and healthcare professionals.

Key Responsibilities

• Participation in the innovation of new ideas & evaluation of concepts
• Responsible for component or device design, including fully dimensioned CAD drawings, material selection meeting biocompatibility requirements, bill of materials, supplier liaising, etc
• Responsible for design related Risk Analysis (Design FMEA)
• Responsible for definition of Design Verification protocols, data analysis and report generation
• Responsible for ensuring that design activity is fully documented per Design Control requirements
• Internal liaison and knowledge transfer to Manufacturing, Quality, Clinical Services and Marketing
• Liaison with customers including surgeons and medical professionals to establish new product requirements
• Responsible for planning and coordinating activities assigned by Core Teams to ensure completion of deliverables in line with project plan
• As required, lead discussions at Design Review, report to Design Review team regarding project timescales/ costs etc
• As required, authority, accountability and day-to-day responsibility for delivering project in line with agreed objectives

Essential Qualifications & Experience

• Engineering Graduate BSc (or Equivalent) in Mechanical Engineering, Product Design Engineering, or relevant discipline
• Relevant previous experience
• Proven ability with component design & development
• Proven ability to work effectively as part of a team
• Clear and efficient communication skills
• Planning & organising skills with ability to work to deadlines (Use of MS Project)
• Effective decision maker
• Effective presentation skills (MS PowerPoint)
• Ability to document work in line with Design Control & Quality Systems including FMEA
• Generation of Engineering Drawings (3D Solid Edge, Solid Works)

We are recruiting an Equipment Engineer to join our Engineering team. This role plays a key part in maintaining, improving and developing production and test equipment to support safe, efficient and compliant manufacturing operations.

Working in a highly regulated environment, you will contribute to equipment reliability, yield improvement and continuous improvement initiatives, while ensuring full compliance with Quality Management System (QMS), Health & Safety and Environmental requirements.

Key Responsibilities

• Carry out routine maintenance, calibration, preventative and reactive maintenance on production, process and test equipment
• Diagnose faults, carry out repairs and implement equipment modifications
• Manufacture, assemble and install new equipment in line with specifications and H&S standards
• Support the design and development of new equipment and engineering improvements
• Contribute to equipment and process validations in collaboration with Manufacturing Engineering
• Develop, maintain and improve equipment performance KPIs, including MTTR and MTBF
• Maintain accurate equipment asset records, spares requirements and asset replacement strategies
• Ensure all activities are completed in compliance with the Quality Management System and audit readiness requirements
• Actively promote and support Health, Safety and Environmental best practice
• Undertake ad-hoc engineering duties as required

Quality, Compliance & Safety

• Work in accordance with company policies, procedures and authorisation limits
• Maintain awareness of how individual activities contribute to overall quality objectives
• Ensure accurate completion of records and promptly escalate any quality-related issues
• Support audit readiness across facilities, processes and documentation at all times
• Take responsibility for personal safety and the safety of others, raising EHS concerns proactively

Knowledge, Skills & Experience

Essential:

• Degree qualified in Electronics, Mechanical or Mechatronics Engineering, or equivalent relevant industry experience
• Electrical / electronic experience within a multi-disciplined engineering environment
• Experience working with production or test equipment in a manufacturing setting
• Strong fault-finding, problem-solving and continuous improvement mindset

Desirable:

• Experience working within a regulated or medical device environment
• Knowledge of equipment calibration, validation and KPI development
• Specific training in relevant HASAWN technology areas