Senior Surgical Instrument Validation Specialist

Job Title: Senior Surgical Instrument Validation Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

About the Role

We are seeking an experienced Senior Surgical Instrument Validation Specialist to provide technical oversight and documentation review for the validation of surgical instruments and reusable medical device systems. The role focuses on assessing validation protocols, reviewing test evidence, evaluating instrument functionality and durability data, and supporting compliance with applicable medical device quality and regulatory requirements.

This fully remote position requires strong knowledge of surgical instrument design, verification and validation methodologies, cleaning and sterilization validation principles, material performance, and medical device quality systems. The specialist will collaborate with engineering, laboratory, manufacturing, infection prevention, quality assurance, and regulatory affairs teams to ensure that validation evidence is complete, traceable, and technically sound.

Key Responsibilities

• Review and assess validation protocols for reusable and single-use surgical instruments and associated accessories.
• Evaluate design verification and validation documentation against approved product requirements and intended-use specifications.
• Review functional testing evidence for surgical instruments, including cutting, grasping, clamping, retracting, dissecting, and articulation mechanisms.
• Assess durability and lifecycle testing results, including repeated-use cycles, mechanical fatigue, wear, corrosion, and structural integrity.
• Review cleaning validation protocols and reports for reusable instruments, including assessment of cleaning effectiveness and residual contamination.
• Evaluate sterilization validation documentation for applicable sterilization methods, including steam, ethylene oxide, and other approved processes.
• Review packaging integrity, transport simulation, and shelf-life validation evidence where relevant to instrument systems.
• Assess material compatibility, surface finish, corrosion resistance, and biocompatibility documentation in coordination with relevant specialists.
• Review test methods, acceptance criteria, sampling strategies, and documented rationales for validation activities.
• Examine laboratory reports, raw data summaries, equipment calibration records, deviations, and test execution documentation.
• Evaluate whether validation evidence adequately represents worst-case instrument configurations and intended clinical use conditions.
• Coordinate with qualified laboratory teams to clarify testing methods, discrepancies, and technical findings.
• Review design changes, component substitutions, manufacturing process modifications, and their potential impact on existing validation evidence.
• Support risk management activities by reviewing instrument-related hazards, failure modes, and the effectiveness of risk control measures.
• Maintain validation matrices, traceability records, technical assessment reports, and controlled documentation.
• Identify gaps in validation packages and coordinate corrective action recommendations with engineering and quality stakeholders.
• Support internal and external audits by organizing technical evidence and demonstrating compliance with approved validation procedures.
• Monitor applicable medical device standards and regulatory guidance affecting surgical instrument verification, validation, cleaning, and sterilization.
• Prepare technical summaries covering validation status, outstanding issues, test limitations, and recommended actions.
• Provide guidance to cross-functional teams on validation documentation quality, evidence traceability, and lifecycle change assessment.

Qualifications and Experience

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Medical Device Engineering, Materials Science, or a related discipline.
• Significant professional experience in surgical instrument validation, medical device quality assurance, product verification, or validation engineering.
• Strong understanding of surgical instrument design, operating principles, intended use, and performance requirements.
• Experience reviewing functional, mechanical, durability, and lifecycle testing documentation for medical devices.
• Knowledge of cleaning validation and reprocessing principles for reusable surgical instruments.
• Familiarity with sterilization validation methodologies and relevant standards, including applicable ISO 17664, ISO 17665, ISO 11135, or ISO 11137 requirements.
• Understanding of medical device quality management systems, particularly ISO 13485.
• Familiarity with risk management principles under ISO 14971 and design control requirements.
• Knowledge of relevant instrument testing standards and applicable regulatory expectations.
• Experience reviewing laboratory protocols, test reports, deviations, equipment records, and validation summaries.
• Understanding of material properties, corrosion resistance, surface treatments, and biocompatibility considerations.
• Ability to assess sampling strategies, acceptance criteria, test reproducibility, and validation traceability.
• Familiarity with electronic quality management systems and controlled document management platforms.
• Strong analytical, technical writing, and problem-solving capabilities.
• Excellent communication and cross-functional coordination skills.
• High attention to detail and commitment to patient safety, product quality, and regulatory compliance.

What We Offer

• 100% remote working arrangement within the stated UAE employment framework.
• Opportunity to contribute to surgical instrument safety, product validation, and medical device quality initiatives.
• Exposure to international validation standards and multidisciplinary product development environments.
• Collaborative working environment with opportunities for professional development and technical leadership.
• Competitive compensation based on experience, qualifications, and technical expertise.

How to Apply

Interested candidates should submit an updated CV highlighting their surgical instrument validation experience, medical device testing knowledge, cleaning and sterilization validation exposure, and quality documentation expertise.

Application subject line: Application – Senior Surgical Instrument Validation Specialist (UAE Remote)

Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.

• Role boundary: This position is fully remote and focuses on validation planning support, technical data review, documentation assessment, and quality coordination. Physical instrument testing, disassembly, cleaning, reprocessing, sterilization cycles, laboratory experiments, equipment operation, clinical-use evaluations, and on-site inspections must be performed by qualified local personnel in appropriately equipped facilities. Clinical judgments, patient-care decisions, formal validation approvals, sterilization process release, product batch release, regulatory submissions, and statutory quality sign-offs must be performed or approved by appropriately qualified and authorized professionals.