- Education / Educación: Bachelor's Degree in Engineering or a similar career.
- Experience / Experiencia: At least 5 years' experience, with 3 of them in a medical device process and/or product development environment is preferred. Desirable previous experience in people management.
- Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): Experienced with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485 and Medical Devices Directive. Experienced with ISO 14971, Risk Management. Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution. Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment. Preferred: Working knowledge of root cause failure analysis, statistical methods, and design of experiments. Proficiency in statistical analysis and tools (MiniTab and Lean Six Sigma knowledge preferred). Strong knowledge of design verification and validation activities. Proficiency using CAD tools (SolidWorks) and, preferably, Finite Element Analysis tools. Strong knowledge of Good Laboratory Practices and QSR (Quality Systems Regulations). Strong knowledge of fabrication methods (DFM), including injection molding, plastic extrusions, ultrasonic and laser welding, metal machining. Strong communication and conflict resolution skills. Experienced in Design Controls and Product Lifecycle Management systems. Experienced in Project Management.
- Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/Fluent English
- Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: Proficiency skills in Microsoft Word, Excel, Outlook, PowerPoint, Project, and other office software programs Oracle knowledgeable.
- Qualifications / Cualificaciones: Problem solving Understanding others Decision quality Peer relations Organizational agility Drive for results Planning & Informing
- Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
- Essential duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs: Assume technical lead role on a cross-functional team focused on the maintenance of on the market products, design changes, and product sustaining including related testing, assuring design verification and validation activities are appropriate and compliant to confirm product inputs requirements are met. Participate independently on sustaining product projects, assuring project is clearly defined and stays on track, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed. Manage product design by troubleshooting product, process, and component issues during the Validation and verification activities. Lead and complete root cause analyses following root cause failure analysis methodologies and providing quality solutions to address identified root causes. Coordinates and lead resources (people and equipment) to ensure that strategic and project goals are being met. Develop solutions for design, process, and quality issues through the application of engineering principles, analysis, and empirical methods identifying possible root causes as part of the verification and validation activities. Work collaboratively with DA and RA to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies. Accountable for the creation, review, correction, enhancement of drawings and documentation to meet or exceed internal and external requirements. Must maintain project and documentation control, especially of design changes and/or proposals. Participates in the development of mechanical and/or electromechanical requirements, system requirements, hardware architecture, risk analysis and risk mitigation. Establish collaborative relationships with stakeholders within the division and network with experts within and outside Hologic. Troubleshoot design and component issues to support maintenance of business activities. Ideate, Design & prototype fixtures and establish methods to support design verification/validation activities. Develop test methods and protocols and complete reports for design verification, design validation, test methods verification and support process validation activities. Execute Protocols and laboratory notebook studies. Maintain accurate records of testing strategies and outcomes. Support completion of Design History File Documentation per FDA and other compliance requirements. Coordinate work with outside vendors and internal personnel including material procurement and testing. Interact with internal and external customers to resolve product application issues. Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc. related meetings and other site efforts meetings reviewing and responding to emails and other messaging platforms.
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R&D Sustaining Engineer 3 CR - Alajuela, Costa Rica - Hologic, Inc.
