Science,Science|Scientific Validator,Engineering|Systems Engineer,Engineering Jobs

• Strong working knowledge of Medical Device Quality Management Systems (QMS) and regulatory requirements including FDA 21 CFR Part 820, ISO 13485, risk management, CAPA, change control, document control, and validation processes.
• Experience in CAPA investigation, remediation, implementation, and effectiveness verification (VoE) activities in a regulated medical device environment.
• Hands-on experience with Spreadsheet Validation, Computer System Validation (CSV), software validation, and validation lifecycle documentation.
• Ability to perform risk assessments, impact assessments, gap analyses, and root cause investigations using quality tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
• Experience in creation and review of Validation Plans, Validation Reports, Traceability Matrices, Risk Assessment Reports, and Quality Records.
• Strong understanding of change management and document control processes, including controlled document updates, routing, approval workflows, and implementation.
• Experience supporting quality system compliance with internal procedures and global standards for spreadsheet and software validation activities identified in CAPA remediation efforts.
• Proficiency in Microsoft Office applications, particularly Advanced Excel, including formula review, data analysis, spreadsheet controls, cell protection, and audit trail documentation.
• Experience working with electronic QMS platforms such as Greenlight Guru, or equivalent document management systems.
• Ability to analyze quality data, prepare status dashboards, track actions, and generate management reports.
• Strong stakeholder management, communication, and project coordination skills in a cross-functional and global environment.
• Knowledge of manufacturing, quality assurance, supplier quality, process validation, and regulatory compliance within the medical device industry.

Job Description:
In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.
Responsibilities:

• Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
• Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
• Facilitate risk assessments to identify validation deliverables and project requirements.
• Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
• Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
• Analyze validation data and troubleshoot issues in collaboration with technical teams.
• Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

• Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
• Hands-on experience in validating computerized systems.
• Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
• Ability to work effectively in a dynamic, cross-functional team environment.
• Proven expertise in applying data governance measures and creating impactful data visualizations.
• Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
• Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.

Summary:
Seeking a Senior Systems Verification and Validation (V&V) Engineer. The selected candidate will work as a V&V Lead to coordinate all V&V activities necessary to support the release of new and updated medical devices. Focus will be assessing and testing the requirements of electromechanical medical devices at the part, sub-system, and system level, investigating test issues, and assisting V&V technicians. Examples of electromechanical devices include ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and the accessories necessary for proper functionality of these types of devices. Examples of test equipment include TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung. Roles & Responsibilities:

• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
• Interact with cross-functional project teams to provide inputs to project plans and schedules.
• Estimate resource needs for project support.
• Review requirements and scrutinize for testability.
• Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
• Assign project tasks and responsibilities to V&V team.
• Act as advisor to team to meet schedules and solve technical problems.
• Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
• Execute test procedures both personally and using test technicians.
• Log defects and issues found during V&V activities and track to closure.
• Participate in defect review boards.
• Perform regression analysis and determine testing associated with design changes.
• Plan and facilitate V&V formal technical review and design review meetings.
• Provide weekly project status reports.
• Prioritize project tasks to complete on schedule while maintaining quality of work.
• Work in a team environment; peer review work.
• Work on multiple, concurrent projects.

You are a part of:

• Our group works closely with the development team throughout the product development process. We play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase. While having our own responsibilities within the group, we look to each other's strengths for support in doing our jobs.

Must Have Qualifications:

• Bachelor's degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
• 5 years professional experience in the medical device industry. Working knowledge of global medical device regulations, requirements, and standards.
• Experience developing V&V test plans, test procedures, requirements trace matrices, and test reports
• Experience validating test methods (TMV) using methods such as DOE and Gage R&R
• Experience with ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and associated accessories
• Experience with specialized test equipment such as TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung.

Preferred Qualifications:

• Bachelor's degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
• 5 years professional experience in the medical device industry.
• Working knowledge of global medical device regulations, requirements, and standards.
• Experience developing V&V test plans, test procedures, requirements trace matrices, and test reports
• Experience validating test methods (TMV) using methods such as DOE and Gage R&R
• Experience with ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and associated accessories
• Experience with specialized test equipment such as TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung.

Job Description:

• In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:

• Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
• Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
• Facilitate risk assessments to identify validation deliverables and project requirements.
• Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
• Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
• Analyze validation data and troubleshoot issues in collaboration with technical teams.
• Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

• Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
• Hands-on experience in validating computerized systems.
• Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
• Ability to work effectively in a dynamic, cross-functional team environment.
• Proven expertise in applying data governance measures and creating impactful data visualizations.
• Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
• Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.

Job Description:

• In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:

• Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
• Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
• Facilitate risk assessments to identify validation deliverables and project requirements.
• Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
• Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
• Analyze validation data and troubleshoot issues in collaboration with technical teams.
• Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

• Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
• Hands-on experience in validating computerized systems.
• Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
• Ability to work effectively in a dynamic, cross-functional team environment.
• Proven expertise in applying data governance measures and creating impactful data visualizations.
• Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
• Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.

• Strong working knowledge of Medical Device Quality Management Systems (QMS) and regulatory requirements including FDA 21 CFR Part 820, ISO 13485, risk management, CAPA, change control, document control, and validation processes.
• Experience in CAPA investigation, remediation, implementation, and effectiveness verification (VoE) activities in a regulated medical device environment.
• Hands-on experience with Spreadsheet Validation, Computer System Validation (CSV), software validation, and validation lifecycle documentation.
• Ability to perform risk assessments, impact assessments, gap analyses, and root cause investigations using quality tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
• Experience in creation and review of Validation Plans, Validation Reports, Traceability Matrices, Risk Assessment Reports, and Quality Records.
• Strong understanding of change management and document control processes, including controlled document updates, routing, approval workflows, and implementation.
• Experience supporting quality system compliance with internal procedures and global standards for spreadsheet and software validation activities identified in CAPA remediation efforts.
• Proficiency in Microsoft Office applications, particularly Advanced Excel, including formula review, data analysis, spreadsheet controls, cell protection, and audit trail documentation.
• Experience working with electronic QMS platforms such as Greenlight Guru, or equivalent document management systems.
• Ability to analyze quality data, prepare status dashboards, track actions, and generate management reports.
• Strong stakeholder management, communication, and project coordination skills in a cross-functional and global environment.
• Knowledge of manufacturing, quality assurance, supplier quality, process validation, and regulatory compliance within the medical device industry.