Job Title: Design Quality Engineer - Software Validation Vacancy Name
Vacancy Name Design Quality Engineer - Software Validation
Location of Work
Employment Type
Employment Type Full Time Employee
Job Description
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
Remarkable service - A seamless, personal process designed around you and your needs.
Trusted performance - Our product family is the result of years of experience championing surgeons and listening to their expertise.
Outstanding value - No matter the surgical specialty, we deliver quality products for all markets.
Our people promise
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
What you will do
As the Design Quality Software Validation Engineer, you will: Design, develop, and implement software validation test strategy, test plans, test automation scripts, and test procedures to meet requirements. Coordinate all validation activities through constant communication with key stakeholders. Be responsible for providing all documentation required to support assembly equipment. This includes but is not limited to operating instructions, electrical schematics, specifications, parameter settings, software backups etc. Address appropriately related manufacturing issues daily as needed Troubleshoot PLC's, Electrical Schematics, and Vision systems. Create and provide equipment specifications to vendors for quoting automated and manual equipment Support the development, implement various product, and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Design and conduct experiments for process optimization and/or improvement Follow and help develop best practices and standard procedures. Act as a Quality liaison within project teams, guiding quality measures throughout the software development lifecycle and overseeing quality-related documentation. Integrate quality practices into software development, scientific computation, and data acquisition processes. Evaluate and approve software project deliverables, ensuring compliance with procedural standards . Conduct risk assessments, manage risk mitigation activities, document product risks, and liaise with the risk management team for updates. Maintain adherence to company's quality processes in software development and risk management efforts. What you will need (job requirements) Bachelor's degree in Engineering or equivalent education and experience 3+ years of experience with electrical/control design experience within medical device. Experience with WHAT TYPE OF PLC's and supporting development software Proficient understanding of FDA and international regulations, including QSRs, ISO. Over 2 years of experience in software Quality Assurance within the medical devices sector or other FDA-regulated industries, covering the full product lifecycle from conceptual design to market release. Experience managing the Design Control process, including participation in design reviews and the maintenance of design history files. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills Experience implementing various product and process improvement methodologies Ability to work within a team and as an individual contributor in a fast-paced, changing environmen Fluent in Spanish and English required
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