Principal Test Engineer

Job Type : Full Time Location : San Diego, California Pay : Competitive Pay, Benefits and Stock Options! Job Description

• Conducts product pre-V&V, verification, and validation testing for product performance and reliability, compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements, and related specifications.
• Leads system-level test activities for our capsule program, which include mechanical, electrical and system level testing.
• Facilitates cross-functional knowledge and experiences to promote the understanding and resolution of product development issues.
• Collaborate closely with design and quality engineering to develop strategies, plans, and specific methods for system level, electro-mechanical testing for our devices with priority focus on accuracy and reliability.
• Serves as a resource to examine system behavior issues and help bring robust tests methods/solutions.
• Collaborate with quality and design engineering, identifying and understanding relevant standards to ensure scope of testing is in compliance.
• Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.
• Design and create models, fixtures, assembly techniques utilizing fabrication skills for electro-mechanical devices.
• Performs other duties as they are identified to support cross-functional teams.

• Minimum bachelor s degree (BS in ME, EE, or related field preferred).10yrs. of experience testing electromechanical systems, medical devices preferred.
• Familiarity with Instron, high speed cameras, oscilloscopes and other systems used for testing and data acquisition.
• Experience with requirements and risk management.
• Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.Experience with statistical data analysis and detailed report writing.
• Experience with creation of specification for custom testing setups.
• Experience with IEC 60601.Direct and coordinate manufacturing support, documentation, and testing activities to ensure compliance with specifications, and product requirements.
• Strong analytical, numerical, and reasoning abilities.
• Write and review requirements for test equipment/methods.
• Ability to read and understand technical electrical and mechanical schematics.
• CAD design and engineering drawing proficiency - SolidWorks preferred.
• Gantt Charts and project plans creation ability.
• Proficiency in writing test protocols, conducting tests, and generating reports.
• Basic electronic troubleshooting ability preferred.
• Hands on mechanical prototyping abilities a plus.
• Experience with MatLab and MiniTab or equivalent preferred.
• Strong analytical and organizational skills to solve complex problems.
• Willingness to and capability of taking ownership of projects, driving them to successful completion.
• Excellent written and verbal communication skills.
• Ability to work as a collaborative team member as well as independently.
• Excellent attention to detail, producing high quality output.
• Ability to initiate and manage time and resources effectively.
• Experience in a machine-shop a plus.
• Ability to follow schematics and debug electronic assemblies a plus.
• Familiarity with domestic and international regulations and industry guidance (e.g., ISO, FDA guidance and CE Mark requirements) is a bonus.
• Ability to handle multiple project and priorities with exceptional organizational and time management skills.
• Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization and lead with influence.
• Proactive, forward-thinking, and creative with high ethical standards, leadership skills and ability to influence others to achieve successful outcomes and meet timelines.
• Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment.
• Strong team player aligned with company s Corporate Values.