SQA Test Engineer 3, R&D CR

at  Hologic

• Education / Educación:

o Bachelor’s Degree (Technical Degree Preferred) may have master’s degree, may have PhD (Systems Engineering, Biomedical Engineering, Computer Science or other related discipline).

• Experience / Experiencia:

o Minimum of 5 years of professional experience, with a bachelor’s degree, in positions with a similar level of responsibility, decision-making and problem solving. Recognized expertise within a similar organization.

• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):

o Thorough understanding of operating systems (including real-time) embedded and application 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 Ability to read and understand technical drawings including mechanical drawings, schematics and circuit diagrams to identify control signals and processor inputs.
o Exceptional working knowledge of test automation and its application in software and hardware environments
o Excellent knowledge of electronics, electro-mechanical equipment, soldering and PCB design programming and testing, analog and digital electronics, and sensors
o Proficient in use of technical equipment such as multimeter, oscilloscope, etc
o Excellent written and verbal communication skills, particularly in communicating technical details with both technical and non-technical audiences. Adapts communication style to suit different audiences Creates precise, accurate technical documentation. Able to facilitate group discussions.
o Strong contributor to a high performing team. Demonstrated ownership in executing project test plans to deliver test procedures and artifacts.
o Ability to provide feedback on requirements and test cases for completeness, accuracy, and ability to implement and test.
o Ability to drive departmental best practices and process improvements.
o Medical imaging or experience in an FDA-regulated environment is beneficial.
o Ability to meet project deadlines and fluidly transition between multiple simultaneous projects is beneficial.
o Experience with Good Laboratory Practices and QSR (Quality Systems Regulations)

o Experience in understanding, troubleshooting and resolving common issues with equipment and processes.

• 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
o Ability to facilitate group discussions
o Strong decision making and technical leadership abilities

The Senior Systems Test Engineer designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment for all phases of product development. The successful job holder will continually strive to understand how complex hardware/software systems operate and find ways to improve them. This individual prepares test and diagnostic programs, designs test fixtures and equipment, and completes test protocols and procedures for new and existing products.
The Senior Systems Test Engineer works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. This individual will demonstrate good judgment in selecting methods and techniques for obtaining solutions. They will need to network with senior internal and external personnel in their area of expertise.
The Senior Systems Test Engineer is a seasoned, experienced professional with a full understanding of systems, embedded software, application software, and hardware testing and resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. The job holder normally receives little instruction on day-to-day work, and general instructions on new 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 Works closely with other test engineers, hardware/software developers and architects to develop an expert level of understanding of our products and their use in clinical practice to design, develop and test our next generation diagnostic systems.
o Functions as a technical expert and acts as lead for assigned products or subsystems.
o Owns design and development of test and validation methods for test equipment. Write plans, procedures, and protocols for software/hardware testing activities. (verification and/or validation). Execute verification and/or validation protocols.
o Accountable for defining requirements, developing, and implementing test fixtures/equipment and corresponding specifications and procedures.
o Accountable for identifying, diagnosing, and prioritizing technical issues that may arise in testing, manufacturing, and from customers.
o Evaluates and develops testing parameters and outputs for trending analysis. Analyzes defects, provides feedback, and implements process improvements.
o Accountable for ensuring that all safety, functional and third-party requirements are captured during system level test.
o Participates in design reviews, creates test plans, defines test requirements, develops test specifications, and defines user interface requirements for test equipment as it relates to new product introduction.
o Provides regular communication and updates on success factors such as progress, schedule, budget, project risks and resource or needs gaps.
o Acts as a technical leader by continuously searching for potential product improvements and insisting on the highest levels of product quality.
o Maintains strong network and relationships with Design Assurance, Regulatory Affairs, Clinical Affairs, Clinical Applications, and other functional partners.
o Interfaces with Product Management and Domain Experts to identify product improvements and influence quality and testability of new product features.
o Applies and shares knowledge of best practices in software, hardware, and systems testing.
o Influences processes to drive product quality.
o Participates in professional development and stays current with new test technology and processes while actively seeking to implement new technology into new and existing design verification & validation activities.
o Provides technical guidance, mentoring, and training for lower-level Test Engineers.