Manufacturing Engineer (Instrumentation)
Location: Trowbridge
Contract Type:12-Month Fixed Term
Role Overview
A manufacturing engineer is needed to design, implement, monitor and maintain manufacturing processes and work instructions within the medical device industry. The organisation is a diagnostics business developing rapid molecular point-of-care testing for infectious disease. This role sits at the interface between design, quality and external manufacturing partners, ensuring products can be built reliably, consistently and at scale.
Key Responsibilities
- Review manufacturing processes and workflows to identify opportunities for improvement, working closely with line operators, component vendors and key suppliers.
- Support verification and validation of the production line at a contract manufacturer, ensuring suitable test suites, including in-line process controls, are defined and implemented.
- Apply working knowledge of product design and assembly to the manufacturing process.
- Maintain process documentation, including technical reports such as process capability studies, bills of materials and process specifications, in line with regulatory and quality assurance requirements.
- Develop processes and procedures that enable the business to meet production targets.
- Design systems and equipment that reduce time and cost while improving quality and safety.
- Work with design engineers to refine product designs for ease of manufacture and assembly.
- Ensure products and sub-assemblies can be manufactured reliably and perform consistently.
- Manage projects using sound engineering principles and techniques.
Experience
- Proven experience in medical device or diagnostics manufacturing, owning and improving manufacturing processes within a regulated industry.
- Experience supporting manufacturing transfer, scale-up and production in collaboration with contract manufacturers or other external partners.
- Experience working with suppliers and cross-functional teams, including design engineering and quality.
- Demonstrated experience maintaining manufacturing documentation within a Quality Management System (for example, ISO 13485).
- Hands‑on experience of process development, troubleshooting and continuous improvement initiatives.
- At least 5 years’ experience in a regulated industry where quality systems are essential (for example, ISO 13485).
Skills
- Familiarity with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles
- Knowledge of manufacturing methods relevant to instrumentation or electromechanical assembly.
- Ability to design and implement efficient, scalable manufacturing processes.
- Strong understanding of verification and validation (V&V), including process validation and in-line testing strategies.
- Strong analytical and problem-solving skills, with a hands‑on approach to troubleshooting and experimentation.
- Excellent verbal and written communication skills
- Strong teamwork skills.
- Able to manage projects with minimal supervision.