Apex Systems, Inc Systems Engineer II (828875) in Louisville, Colorado

DescriptionApex is seeking qualified Electrical Engineers in the Boulder, CO area thathave 5+ years' experience in the medical device/biotechnology industry.Preferred experience includes CAPA resolution, verification andvalidation, failure analysis, and much more. For immediateconsideration, please send your resume to zburrell@apexlifesciences.comPOSITION TITLE:Senior Systems/Sustaining EngineerMust Haves:Electrical Engineering degreeTesting/V&V experience (hardware and software)Regulated industry experience highly desiredSome OT is anticipatedSUMMARY OF POSITION:Within the Health Informatics & Monitoring R&D Systems Engineeringgroup, the sustaining engineer s primary responsibility will be to supporthardware aspects of Remote Patient Monitoring products currently on the marketas well as support new product development activities.The sustaining engineer will research and validate electrical/electronic andIT-related components, materials and applications while sustaining currentproduct designs.The engineer is responsible for the design history files, determining testrequirements and coordinating V&V testing.In addition to implementing moderate design changes that either enhanceperformance or address quality issues, the sustaining engineer performsformal root cause investigations, determines root cause failure modes andprovides solutions for these issue in that above product lines.ESSENTIAL FUNCTIONS:Provides technical support for existing products as well as product underdevelopment by developing solutions for problems moderate to complex in natureand/or of moderate organizational impact with a high level ofaccountability, moderate level of authority and some supervisory oversight.Works to maintain product performance and quality for existing products byleading and assisting with issues relating to CAPAs, customer complaints andmanufacturing processes, such as:Failure investigation and root cause analysisCAPA resolutionRegulatory complianceProduct Design Verification and Design ValidationDesign changesTest methods and tooling designProcess enhancement and improvementProvides research on components, modules and assemblies for RoHS compliance.Follows strict adherence to policies and procedures associated with an FDAcontrolled environment.Generates Engineering Change Orders to support product sustaining efforts.Works with clinicians technical issues and communicates solutions at theappropriate level.Identifies immediate solutions for short term corrections to prevent impact tobusiness goals.Accurately estimate tasks and track/communicate project progressProvide technical guidance to junior level sustaining engineers and/oroff-shore engineersWorks to integrate product performance activities with new product developmentto improve project delivery time and reduce post release production issues.DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:Prepares analysis reports for director(s), project leaders or other personnel.Presents project status to management and teams, as required.Develops and tracks work schedule and assignments.Process documentation through document release system.Works on process improvement activities.Provides input to departmental planning and resource activities.Other duties as assigned with or without accommodation.MINIMUM REQUIREMENTS:Education:BSEE or equivalent with Electro/mechanical experience and product life cycles.Experience:5 years of experience working in a multifaceted environment with internal andexternal customers in a technical support role.Sustaining engineering RoHS programs, product design and project managementexperience.Experience with wireless communication hardware and correspondinginternational standards as well as IT networking is a plus.Preferred Skills/Qualifications:Demonstrated experience and a proven track record of success in productsupport evidenced by lowered support or warranty costs and by a failure ratereductionExperience with internal and outsourced sustaining development projectsPr