OVERVIEW :
The Materials Project Engineer will lead projects to improve the performance, manufacturing processes, and supply chain continuity of the RxSight Light Adjustable Lens (LAL). This role involves collaboration with various departments to execute plans, conduct studies, and develop systems for monitoring and managing materials. Projects and initiatives include those focused on improving performance, manufacturing processes and capacity, supply chain continuity, and quality of the RxSight Light Adjustable Lens (LAL).
You will be responsible for ensuring that qualified sources of supply are established for all critical LAL materials. You will actively collaborate with Operations and R&D departments to drive projects by creating and executing plans. You will develop a comprehensive understanding of all project paths and studies, owning and constantly iterating these processes to maximize efficiency and accuracy.
Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES :
Materials Project Leadership :
- Assess prospective suppliers and manage change projects to ensure material supply continuity. Change management projects include supplier change requests, engineering change requests, fast-track engineering change requests, and change requests.
- Ensure team visibility into materials initiatives and identify opportunities to streamline projects and processes.
- Take an active role in managing and coordinating R&D and engineering studies including ensuring timely execution of activities such as manufacturing builds and biocompatibility and chemical characterization studies.
Product Safety Competence Center :
Provide technical leadership and facilitate process improvement for qualifying LAL materials.Lead risk-assessment of material changes and develop evaluation plans for early and late-stage development projects.Maintain a repository of documented test results.Risk-assess proposed changes, and advise on feasibility screening tests, qualification strategy, regulatory strategy, and potential performance impacts.Develop biological evaluation plans and lead biological evaluation, including risk assessment, protocol and report writing, test article preparation, and coordination and monitoring of testing with outside laboratories. Collaborate with key departments proposing changes, including engineering, chemistry, and operations.Process Development and Manufacturing Transfer :
Ensure transfer of material change projects to commercial manufacturing including driving technical documentation readiness (manufacturing work instructions, manufacturing process travelers, and technical reports).Document results and assist project teams in resolving technical issues.Ensure clearly documented results, observations, and reporting throughout the feasibility, process development, verification & validation, and manufacturing transfer phases of the project.Utilize technical expertise and quality and regulatory guidelines to direct and support project teams in resolving technical issues, identifying root causes, developing optimized processes, and making decisions about the course of the project.Materials Continuity Infrastructure - Continuous Improvement :
Regularly review and improve internal processes.Collaborate with teams to ensure visibility into material continuity initiatives.REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES :
Ability to evaluate, generate, and lead change management projects (supplier change requests, engineering change requests, fast-track engineering change requests, and change requests), including collection of requirements, risk assessment, qualification strategy development, regulatory requirements development, project execution, and project closure.Ability to efficiently generate technical documentation including project plans, basic engineering drawings, specifications documents, protocols and reports, biological evaluation plans, work instructions, operating procedures, forms, and portions of regulatory filings as directed.Ability to dissect data, connect results with product performance and product safety requirements, and make comprehensive plans (who, what, when, where, why, how) for next steps based on data results.Desire to continuously improve and streamline existing processes, leveraging work management, process management, and project / process visualization tools such as but not limited to Smartsheet, Microsoft BI dashboards, Microsoft Excel, and Visio.Strong interpersonal skills - the ability to communicate effectively at multiple organizational levels including technicians, Engineering, Chemistry, and Project Management.Clear communicator - understands how to distill information to have substantive discussions with the right audience.Strong Organizational skills - the ability to balance and prioritize multiple studies, and manufacturing builds.Continued appetite to learn about our technology, its performance characteristics, and its manufacturing process - our process and our technology are unique!Self-motivated, proactive, and able to work effectively under minimal supervision.SUPERVISORY RESPONSIBILITIES :
NoneEDUCATION, EXPERIENCE, and TRAINING :
BS in engineering, chemistry, or related disciplineMinimum of 5 years of work experience is preferred in a role that requires strong interpersonal skills, clear communication skills, and strong organization skills.Proven knowledge of material characterization methods.Process analysis and continuous improvement orientation.Familiarity with regulatory standards (ISO 10993, ISO 13485).Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP). Experience with good laboratory practices (GLP) is a plus.Training to be completed per the training plan for this position as maintained in the document control system.The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basisCERTIFICATES, LICENSES, REGISTRATIONS :
NoneCOMPUTER SKILLS :
Word ProcessingBusiness Intelligence software (Power BI preferred)Project Management System (SmartSheet preferred)Salary Description
110,000 - $125,00
