Process Design Engineer

ROLE: Senior Manufacturing and Process Design Engineer

JOB DESCRIPTION

The role of Senior Manufacturing and Process Design Engineer is an exciting opportunity to join a growing medical device company operating to ISO 13485 standards.

Working directly with the leadership team, this senior role will lead the design, development, transfer and improvement of robust manufacturing processes for new and existing medical device products.

The successful candidate will define manufacturing methods, specify and introduce equipment, develop fixtures and tooling, and ensure processes are validated, documented and controlled in line with quality system requirements.

This position is suited to a versatile, hands-on self-starter who is comfortable moving between technical problem solving, process design, validation, production support and cross-functional project leadership. The successful candidate may not have been in a senior role before but will possess the knowledge and experience to perform the tasks described.

The Senior Manufacturing and Process Design Engineer will also have the opportunity to drive efficiency improvements through process reengineering, automation, kaizen events, data-led decision making and structured problem solving.

This role will also provide a wide breadth of exposure to areas such as equipment maintenance, customer visits, Health & Safety, product pricing and as part of an international group working with other engineers globally to resolve problem statements and develop solutions

We are looking for an ambitious engineer with technical depth, initiative and leadership potential to grow with the business and help shape best-in-class manufacturing capability.

This is a high-impact role for someone who enjoys ownership, variety and the opportunity to make a visible contribution in a regulated medical device manufacturing environment.

Key Responsibilities

· Lead the design, development and optimisation of manufacturing processes for new and existing medical device products.

· Support design transfer and new product introduction activities, ensuring product requirements are effectively translated into capable and repeatable production processes.

· Define, specify, source, install and commission manufacturing equipment, tooling, fixtures and test systems.

· Execute process validation plans, protocols and reports, including IQ, OQ and PQ activities where applicable.

· Prepare and maintain clear technical documentation, including process specifications, work instructions, risk assessments, validation records and change control documentation.

· Partner with Quality, Operations, Supply Chain and customer-facing teams to resolve technical issues, improve process performance and support audit readiness.

· Use structured problem-solving tools to investigate process deviations, non-conformances, scrap, rework and yield losses, and implement effective corrective and preventive actions.

· Identify and deliver continuous improvement opportunities in productivity, capacity, ergonomics, safety, quality and cost.

· Assess opportunities for automation and semi-automation, preparing business cases and supporting implementation where appropriate.

· Provide technical coaching and practical support to production, maintenance and engineering colleagues.

· Support customer visits, supplier interactions and cross-site engineering collaboration as required.

· Promote a culture of compliance, safety, ownership and continuous improvement across manufacturing operations.

DESIRED QUALIFICATIONS / SKILLS

· Strong manufacturing process development, process design and equipment validation experience in a regulated manufacturing environment is highly desirable.

· Bachelor’s degree in mechanical, Manufacturing, Biomedical, Polymer, Industrial or related Engineering discipline.

· Ideally 5+ years' experience in medical device manufacturing or an equivalent regulated environment.

· Proven experience leading engineering projects involving equipment introduction, process transfer, new product introduction or manufacturing scale-up.

· Practical experience with equipment, test method and process validation, including protocol generation, execution and report writing.

· Working knowledge of ISO 13485 quality management requirements, change control, risk management and documented evidence expectations.

· Experience with LEAN, Six Sigma, kaizen, value stream improvement or other continuous improvement methodologies would be beneficial.

· Strong problem-solving, critical analysis and root cause investigation skills.

· Ability to manage multiple priorities, meet project milestones and communicate clearly with stakeholders at all levels.

· Versatile, organised and self-motivated individual with initiative, ownership and ambition to grow.

· Available for limited project travel to the U.S.A. and within Europe as required (<10%).