An innovative and expanding medical device company, is seeking a Senior Process Development Engineer to play a pivotal role in the development, optimisation, and scale-up of manufacturing processes. This position offers the opportunity to lead strategic process improvement and automation projects while providing hands-on support to manufacturing operations in a highly regulated environment.
As a Senior Process Development Engineer, you will be responsible for designing, developing, validating, and continuously improving manufacturing processes that ensure products are produced safely, efficiently, and in compliance with industry regulations. You will work cross-functionally with engineering, quality, and production teams to support business growth, operational excellence, and product quality.
This is an excellent opportunity for a motivated engineer who enjoys balancing project leadership with practical manufacturing support and problem-solving.
Responsibilities
Develop, optimise, and validate robust manufacturing processes for medical device products
Collaborate with engineering and production teams to improve manufacturing efficiency, quality, and scalability
Lead automation projects from concept through implementation, ensuring successful integration into existing operations
Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
Apply structured problem-solving techniques to resolve process, equipment, and material-related challenges
Develop and maintain manufacturing procedures, work instructions, and technical documentation
Design and execute process validation activities, including equipment qualification and manufacturing validation protocol
Analyse manufacturing data and implement improvements to enhance productivity, process capability, and reliabilitySupport investigations related to CAPAs, non-conformances, deviations, and audit findings
Evaluate and implement emerging technologies including robotics, vision systems, and digital manufacturing solutions
Provide technical leadership and day-to-day support to manufacturing operations
Develop training materials and support knowledge transfer across production teams
Requirements
Degree-qualified (Level 8 or equivalent) in Engineering or a related discipline
Minimum 5 years' experience in process development, manufacturing engineering, or process improvement within the medical device industry
Proven experience in process validation, manufacturing support, and project delivery
Strong understanding of medical device regulatory requirements, including ISO 13485 and FDA regulations
Experience applying Lean Manufacturing principles and continuous improvement methodologies
Knowledge of statistical tools and techniques including DOE and Six Sigma
Excellent problem-solving, analytical, and decision-making skills
Strong communication and stakeholder management abilities
Experience with engineering design software such as AutoCAD or SolidWorks is advantageous
Lean Six Sigma Green Belt certification is desirable
What's on offer
Opportunity to join a growing and innovative medical device organisation
Exposure to advanced manufacturing and automation technologies
A highly collaborative and supportive engineering environment
Career progression opportunities within a rapidly evolving business
Competitive salary and benefits package
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