Principal MES Engineer – MES Testing & Validations (USA Remote Position)

Edwards Lifesciences

Boston Massachusetts

United States

Engineering
(No Timezone Provided)

The Principal Engineer will be an essential member of the Digital Transformation Organization. This role will report into the Senior Director and be responsible for partnering with key stakeholders to drive testing and validation strategies to support Manufacturing Execution System (MES). In addition, this role will provide expertise in testing principles and methods to drive robust testing, validation, and support of technical solutions.Other Essential Key Responsibilities:Planning and driving MES testing and validation ensuring that all targets and requirements are met by serving as a liaison across businesses and functionsPartnering with IT organization to deliver validated solutionsCollaborating with business partners to define validation strategy and execution to improve productivity, maintain compliance and improve operational performanceLeading and managing the validation of systems from initiation to completion and maintenanceDefining and developing processes and documents for automated testing tools, risk-based testing, regression testing, and test protocols by leveraging industry leading practicesGuiding team members and partner with vendors to develop and document test strategy, scenarios, and protocolsPartnering with Software Quality to ensure system complies to regulations and meets intended useCommunicating project updates and progress to higher level managementUnderstanding current regulatory bodies supporting Computerized Systems and ensuring all regulations have been met as part of system implementationMinimum Education & Qualifications:Bachelor’s degree in Sciences, Engineering, Computer Science, Software Engineering, Computer Engineering, or similar disciplines with 10 years of experience in either Software Quality, Testing, Validation, or I.T.; OR Master’s degree in same disciplines with 8 years of experience in either Software Quality, Testing, Validation, or I.T.In-depth familiarity and experience with MES and/or other manufacturing applicationsExperience with Testing software, Software Quality and Test Protocol DevelopmentExperience working within a highly regulated industry.Preferred Qualifications:Medical Device, Pharma, Biotech, Aerospace, or Automotive industry experienceHands-on experience with CAMSTAR MES software testing and validation testing protocolsExperience with validating computerized systems and manufacturing systems preferredKnowledge and experience in implementing CAMSTAR MESStrong knowledge with manufacturing process and product developmentStrong familiarity with GAMP5 guidelines, 21CFR Part 11, Annex 11 and understanding of the predicate rules in context with the SDLC processExtensive knowledge and understanding of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product softwareKnowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software)Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

Principal MES Engineer – MES Testing & Validations (USA Remote Position)

Edwards Lifesciences

Boston Massachusetts

United States

Engineering

(No Timezone Provided)

The Principal Engineer will be an essential member of the Digital Transformation Organization. This role will report into the Senior Director and be responsible for partnering with key stakeholders to drive testing and validation strategies to support Manufacturing Execution System (MES). In addition, this role will provide expertise in testing principles and methods to drive robust testing, validation, and support of technical solutions.Other Essential Key Responsibilities:Planning and driving MES testing and validation ensuring that all targets and requirements are met by serving as a liaison across businesses and functionsPartnering with IT organization to deliver validated solutionsCollaborating with business partners to define validation strategy and execution to improve productivity, maintain compliance and improve operational performanceLeading and managing the validation of systems from initiation to completion and maintenanceDefining and developing processes and documents for automated testing tools, risk-based testing, regression testing, and test protocols by leveraging industry leading practicesGuiding team members and partner with vendors to develop and document test strategy, scenarios, and protocolsPartnering with Software Quality to ensure system complies to regulations and meets intended useCommunicating project updates and progress to higher level managementUnderstanding current regulatory bodies supporting Computerized Systems and ensuring all regulations have been met as part of system implementationMinimum Education & Qualifications:Bachelor’s degree in Sciences, Engineering, Computer Science, Software Engineering, Computer Engineering, or similar disciplines with 10 years of experience in either Software Quality, Testing, Validation, or I.T.; OR Master’s degree in same disciplines with 8 years of experience in either Software Quality, Testing, Validation, or I.T.In-depth familiarity and experience with MES and/or other manufacturing applicationsExperience with Testing software, Software Quality and Test Protocol DevelopmentExperience working within a highly regulated industry.Preferred Qualifications:Medical Device, Pharma, Biotech, Aerospace, or Automotive industry experienceHands-on experience with CAMSTAR MES software testing and validation testing protocolsExperience with validating computerized systems and manufacturing systems preferredKnowledge and experience in implementing CAMSTAR MESStrong knowledge with manufacturing process and product developmentStrong familiarity with GAMP5 guidelines, 21CFR Part 11, Annex 11 and understanding of the predicate rules in context with the SDLC processExtensive knowledge and understanding of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product softwareKnowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software)Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.