Test Engineer

Hira Ni; Belfast City District; On-site; GBP 45,000 - 65,000; Full time

Job summary

Stryker in United Kingdom is seeking a qualified engineer to provide design, technical and operational support to test processes, with focus on GMP-compliant manufacturing and capacity expansion like Pad-Pak.

The role emphasizes cross-functional collaboration, capital equipment projects, IQ/OQ/PQ validation, calibration, EHS and QMS adherence, plus training and presenting to management.

Qualifications

• Level 6 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 & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment.
• Strong communication and influencing skills with both internal and external agents.
• Fostering a working environment of continuous improvement
• Excellent presentation and written / verbal communication skills.
• Capable of working autonomously
• A team player, with a flexible approach.
• 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.
• Provide Technical support for Test equipment and process onsite and offsite and ensure compliance with calibration schedule and requirements.
• Support all capital acquisition activity from specifying equipment, contract negotiation, Installation, and validation.
• Develop or review of test process documents including user requirements, functional specifications, risk assessment, design description, and traceability matrices.
• Development and implementation of appropriate supporting documentation, SOPs, and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
• Develop, implement, or review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Assist in the evaluation of out-of-specification results and associated corrective actions.
• Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day-to-day operating requirements, and in pursuit of achieving the business targets
• Delivers and presents technical and/or training presentations to management, employees, and contractors.
• Observing the Quality Management Systems requirements on site at all times
• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site
• All other duties as assigned.

Skills

Analytical thinking

Problem solving

Communication

Teamwork

Training skills

Autonomy

Lean thinking

Continuous improvement

Presentation skills

Education

Level 6 Degree in Biomedical/Electronic Engineering or equivalent

Job description

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.

Provide Technical support for Test equipment and process onsite and offsite and ensure compliance with calibration schedule and requirements.

Support all capital acquisition activity from specifying equipment, contract negotiation, Installation, and validation.

Develop or review of test process documents including user requirements, functional specifications, risk assessment, design description, and traceability matrices.

Development and implementation of appropriate supporting documentation, SOPs, and process work instructions compliant with current Good Manufacturing Practices (GMP)

Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.

Develop, implement, or review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Assist in the evaluation of out-of-specification results and associated corrective actions.

Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day-to-day operating requirements, and in pursuit of achieving the business targets

Delivers and presents technical and/or training presentations to management, employees, and contractors.

Observing the Quality Management Systems requirements on site at all times

Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site

All other duties as assigned.

Qualifications & Experience

Level 6 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 & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment.

Strong communication and influencing skills with both internal and external agents.

Fostering a working environment of continuous improvement

Excellent presentation and written / verbal communication skills.

Capable of working autonomously

A team player, with a flexible approach.

Capable of training manufacturing team members

United Kingdom Pay Ranges:

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker's comprehensive benefits package.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.