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Test Engineer I (Medical Device or Pharma) : Irwindale, CA

Lancesoft Inc
Irwindale, California, United States
March 21, 2017

The System Test Engineer will be responsible for developing, preparing the installation of, performing and revising test validation procedures/protocols and test reports to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and product specifications. A Test Engineer compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements. He or she may also investigate and troubleshoot problems and determine solutions. He or she maintains appropriate validation documentation and files.

Responsibilities include the development of Validation Protocols for small to medium size validation projects for electrophysiology ablation catheters, system and RF generators. The successful candidate will be responsible for developing protocols using a risk based approach that meets current regulatory requirements and company standards. The Test Engineer will also be responsible for presenting the validation approach and study results to peers, supervisors and managers.

Responsibilities include development of test jigs, operating off the shelf test equipment and develop test methods required to execute procedures and protocols. Successful candidate shall also be able to lead small projects and support project coordination of product changes.

Essential Duties And Responsibilities:

Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and procedures and guidelines, the responsibilities of the position include:

? Developing, preparing the installation of, performing and revising test validation procedures/protocols

? Executes approved validation protocols (e.g. Design V&V protocols, IQ, OQ, PQ) and documents deviations, software failures, and corrective action

? Compiling and analyzing validation data, preparing reports, and making recommendations for changes and/or improvements.

? Logistics, packaging and shipping of equipment required to support validations in remote sites.

? Presenting the validation approach and study results to peers, supervisors and managers.

? Building rough prototypes for test equipment including custom cables and electro mechanical assemblies

? Ensures the collection and archiving of research and development documentation and delivers training documentation on new processes, materials, and equipment.

? Collects samples and files required paperwork.

? Responsible for communicating business related issues or opportunities to next management level

? Responsible for following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

? Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

? Performs other duties assigned as needed

Required education/training and/or experience:

? The Test Engineer should have at least a bachelor's degree in science, or an engineering degree.

? At least 1 year experience in testing real time software/ validation activities

? Hands on experience building and configuring test setups

? Experience in Microsoft office (Word, Excel)

? Experience in performing tests and reporting results

? Experience using Solidworks, Matlab and LabView preferred

? Experience in soldering and assembly preferred

Required knowledge, skills, abilities and certifications/licenses:

? The System Test Engineer must have good computer skills as well as be able to analyze and determine the relevance of data collected.

? Excellent communication skills (verbal and written),

? Acquaintance with use of electronic measurement devices such as oscilloscopes and frequency analyzers is mandatory.

? Problem solving capabilities.

? Good presentation skills.

? Self-driven individual who is capable and excited to learn about new technologies

Additional position requirements:

Up to 25% travel (International as well as domestic).

Weekend travel/work may be required.

Ability to lift 60 lbs