Job details
Job type full-time
Full job description
The principal engineer will be an essential member of the digital transformation organizationThis 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 functions
Partnering with it organization to deliver validated solutions
Collaborating with business partners to define validation strategy and execution to improve productivity, maintain compliance and improve operational performance
Leading and managing the validation of systems from initiation to completion and maintenance
Defining and developing processes and documents for automated testing tools, risk-based testing, regression testing, and test protocols by leveraging industry leading practices
Guiding team members and partner with vendors to develop and document test strategy, scenarios, and protocols
Partnering with software quality to ensure system complies to regulations and meets intended use
Communicating project updates and progress to higher level management
Understanding current regulatory bodies supporting computerized systems and ensuring all regulations have been met as part of system implementation
Minimum 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 applications
Experience with testing software, software quality and test protocol development
Experience working within a highly regulated industry.
Preferred qualifications :
Medical device, pharma, biotech, aerospace, or automotive industry experience
Hands-on experience with camstar mes software testing and validation testing protocols
Experience with validating computerized systems and manufacturing systems preferred
Knowledge and experience in implementing camstar mes
Strong knowledge with manufacturing process and product development
Strong familiarity with gamp5 guidelines, 21cfr part 11, annex 11 and understanding of the predicate rules in context with the sdlc process
Extensive 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 software
Knowledge of and adherence to related procedures (e.g., cybersecurity procedures related to it systems, manufacturing equipment or product software)
E dwards 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 worldAs 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 roleIf 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.
