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Stryker

Manufactures orthopedic and surgical medical devices

Test Engineer

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeBelfast, UK

About the Job

Requirements

  • A Level 6 degree in Biomedical or Electronic Engineering, or equivalent technical experience, is required.
  • Knowledge of quality systems and requirements for regulated environments.
  • Knowledge of the medical devices industry and associated regulations.
  • Knowledge of lean manufacturing principles and practices.
  • Analytical and problem-solving skills, a process-improvement orientation, and ability to handle multiple tasks in a fast-paced, results-oriented environment.
  • Strong communication and influencing skills with internal and external stakeholders.
  • Ability to work autonomously.
  • Ability to train 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 expansion.
  • Provide technical support for test equipment and processes onsite and offsite, and ensure compliance with calibration schedules and requirements.
  • Support capital acquisition activities, including equipment specification, contract negotiation, installation, and validation.
  • Develop or review test-process documents, including user requirements, functional specifications, risk assessments, design descriptions, and traceability matrices.
  • Develop and implement supporting documentation, standard operating procedures, and process work instructions compliant with current Good Manufacturing Practices.
  • Monitor line performance and compile and execute structured event plans to remediate systemic issues that drive suboptimal performance.
  • Develop, implement, or review process validation plans, protocols, and reports associated with Installation Qualification, Operational Qualification, and Performance Qualification.
  • Assist in evaluating out-of-specification results and associated corrective actions.
  • Interface with cross-functional team members and third-party vendors to support day-to-day operating requirements and business targets.
  • Deliver and present technical and training presentations to management, employees, and contractors.
  • Observe the site's Quality Management System requirements.
  • Adhere to and enforce all Environment, Health, and Safety requirements onsite.
  • Perform other duties as assigned.

About the Company

Stryker

Manufactures orthopedic and surgical medical devices

Stryker makes medical devices for hospitals, surgical centers and emergency responders, spanning joint implants, surgical instruments and patient transport equipment. Its Mako platform assists surgeons with joint replacement, while its neurotechnology products support brain and spine procedures and stroke treatment. Clinicians use its equipment during surgery and emergency care, and the company earns money by selling implants, disposable products and capital equipment through direct sales teams and distributors. The business also supplies training and technical support for healthcare providers using its devices. Stryker was founded in 1941 and is headquartered in Portage, Michigan.

Company size
10,001+
Company stage
IPO
Headquarters
Portage, MI
Founded
1941

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