Test Engineer - GMP Validation & Process Excellence

Stryker; Belfast City District; Hybrid; GBP 33,000 - 56,000; Full time

Job summary

Stryker is seeking a Biomedical/Electronic Engineer to support test processes and manufacturing design at our UK site. The role requires developing documentation, validating processes, and ensuring GMP compliance with cross-functional collaboration and external vendors.

The position emphasizes analytical problem solving, effective communication, and training manufacturing teams. It offers on-site work with flexibility options including remote/hybrid arrangements where applicable.

Qualifications

• Degree in Biomedical/Electronic Engineering or equivalent technical experience is required.
• Knowledge of quality systems and requirements of regulated environments.
• Knowledge of the medical devices industry and associated regulation.
• Knowledge of lean manufacturing principles and practices.
• Demonstrable analytical and problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced environment.
• Excellent presentation and written/verbal communication skills.
• Capable of working autonomously and as part of a team; capable of training manufacturing team members.

Responsibilities

• Provide design, technical and operational support to test processes to meet business goals and objectives.
• Support manufacturing process design, validation and implementation for Pad-Pak capacity expanding.
• Develop or review test process documents including user requirements, functional specifications, risk assessment, design description, and traceability matrices.
• Development and implementation of SOPs and process work instructions compliant with GMP.
• Line performance monitoring and remediation of sub-optimal performance.
• Develop, implement, or review IQ/OQ/PQ related validation plans, protocols and reports.
• Interact with cross-functional teams and third-party vendors; deliver technical and training presentations to management, employees and contractors.
• Observe the Quality Management System requirements on site and enforce EH&S requirements.
• All other duties as assigned.

Skills

Analytical skills

Problem solving

Communication skills

Presentation skills

Training capable

Education

Biomedical/Electronic Engineering degree

Job description

Stryker is seeking a Biomedical/Electronic Engineer to support test processes and manufacturing design at our UK site. The role requires developing documentation, validating processes, and ensuring GMP compliance with cross-functional collaboration and external vendors.

The position emphasizes analytical problem solving, effective communication, and training manufacturing teams. It offers on-site work with flexibility options including remote/hybrid arrangements where applicable.