SQA Test Engineer 2, R&D CR
hace 4 semanas
SQA Test Engineer 2, R&D CR
Alajuela, Costa Rica
• Education / Educación:
o University level: A Bachelor of Engineering degree. Equivalent: University diploma or technical certification at least 350 hours.
• Experience / Experiencia:
o Minimum 2 years of experience in the related field in medical device industry.
• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
o Strong understanding of software, hardware and systems testing best practices
o Experience in testing functional, design, and interface aspects of a commercial product at the board, sub-system, and system level
o Skilled in reading and interpreting technical drawings including mechanical drawings and circuit schematics.
o Training, experience, and aptitude for electro-mechanical equipment, soldering and PCB design and testing.
o Experience in using technical equipment such as multimeter, oscilloscope, etc.
o Strong written, verbal, organizational and interpersonal skills. Creates precise, accurate technical documentation.
o Strong contributor to a high performing team
o Experience in understanding, troubleshooting and resolving common issues with equipment and processes.
o Medical imaging or experience in an FDA-regulated environment is beneficial.
o Working knowledge of test automation and its application in software and hardware environments
o Experience with Good Laboratory Practices and QSR (Quality Systems Regulations)
• Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
o Spanish/Fluent English (Written and Oral)
• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
o Basic Skills with MS Office (Microsoft Word, Excel, Outlook, Power Point)
o Competency in statistical analysis and tools (MiniTab preferred)
• Qualifications / Cualificaciones:
o Customer Focus
o Problem Solving
o Informing
o Drive for Results
o Networking
o Creativity, initiative, and vision
o Critical thinking and analytical skills
• Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
The Test Engineer designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment for all phases of product development. This individual prepares test and diagnostic programs, designs test fixtures and equipment, and completes test protocols and procedures for new and existing products.
The Test Engineer at this level works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. These individual exercises judgment within defined procedures and practices to determine appropriate action. They will build productive internal/external working relationships.
The Test Engineer develops professional expertise, applies company policies and procedures to resolve a variety of issues. This individual normally receives general instructions on routine work, detailed instructions on new projects or assignments.
The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
o Develops thorough understanding of our products and their use in clinical practice to design, develop and test our next generation diagnostic systems.
o Responsible for defining and developing test methods and procedures. Performs experiments and validations, collects data, and creates detailed test reports.
o Identifies required hardware/sensors and software components for manufacturing equipment.
o Recommends and supports upgrade and repair of equipment and fixtures.
o Reviews system level documentation (HRS, SRS, etc.) to ensure that all safety, functional and third-party requirements are captured during system level test.
o Continuously works to improve test methods, efficiency, and product quality.
o Works closely with and contributes to cross functional teams.
o Develops network and relationships with Design Assurance, Regulatory Affairs, Clinical Affairs, Clinical Applications, and other functional partners.
o Provide communication and updates on success factors such as progress, schedule, budget, project risks and resource or needs gaps.
o Apply and share knowledge of best practices in software, hardware, and systems testing.
o Lead troubleshooting and failure analysis.
o A strong desire to constantly find smarter and better ways to test Hologic's products, so we can continue providing the best quality of care to our patients. She/he will support and provide feedback to new products by troubleshooting products and component issues.
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