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Senior Component Engineer (Electrical)

Company: Outset Medical, Inc.
Location: san jose
Posted on: May 3, 2021

Job Description:

Company OverviewOutset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone.The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission anda proprietary data analytics platform powering a new holistic approach to dialysis care.Position OverviewThe successful candidate shall have in-depth knowledge and experience in part design and development ofElectrical components and PCBAsfor medical device productmanufacturing;acts as resource and role model for colleagues with less experienceand for vendors. Use standard methodologies and knowledge of internal or external business issues to improve products. Technical lead in his/her respectiveElectricaland Electronicscomponentdesign, complex problem solving, and technology evaluation and deployment to enable efficient manufacturing for balanced, large-scale production.Utilize their knowledge ofElectricaldesign, GD&T practices,materialsand injection molding processes to optimal engineer custom solutions, develop DFM feedback, improve current designs and collaborate with vendors. He/she shall use the experience inPCBAmanufacturing to transition designs from the Concept phase through Development and into Productionat the vendor sites. Through these phase gates of product development and/or new product introduction, apply DFMEA, DFM, and CAE tools to develop robust component designs that encourage manufacturing efficiencies forelectrical and electronics componentsthrough finished device assembly. This is a hands-on position involving detailed design (3D modeling and 2D print specification), testing,prototypingand engineering support of Production;Individual should interface well with team members, scientists, vendors, and operations personnel.Outset is a fast moving, dynamic environment where flexibility and adaptability are key attributes needed for success. The successful candidate will be a highly motivated self-starter withElectricalComponents expertise in consumer electronics, automotive or healthcare industries."Responsibilities:Create, review, and approve Engineering Change Orders for electronic component managementDesign, test, and validate newElectricalcomponent designs in collaboration with multi-disciplined engineering teams.Review and approve component specifications from suppliers.Participates in electrical schematics reviews, validate components for NPI.Lead component specifications in Quality Management System (QMS) and ensure those specifications are applicable to product function and Quality Policy.Proactively identify risks in the design of parts, molds,fixturesand methods associated withElectricalcomponents manufacturing and design quality into the component design rather than relying on inspection to detect non-compliance with design or process intent.Establish working relationships with vendors for outsourcing of engineering services, materials supply,fixturedesign, and contract manufacturing ofElectricalcomponents.Develop high standards for allElectricalcomponent products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised.Lead a core team in failure investigations and root cause analyses as they relate toElectricalparts performanceand manage corrective action with suppliers.Coordinate Engineering testing, first article inspections, and qualification activities.Mentor others to utilize advanced inspection technologies, statistical methods, process data, DOE, to identify required improvements to injection molding tools, processes, and measurement techniques such that robust performance at high manufacturing efficiencies is enabled.Write verification and validation protocols and related technical reports to support the transfer of designs into Production and document status ofElectricalcomponents throughout a product lifecycle.Actively participate in group meetings and be a technical point person in project teams.Create custom fixtures and procedures for testing, inspection, or functional evaluation ofElectricalparts designs and compliance with specifications or intended use.Work with Electrical Design Engineers to select components based on performance, reliability, availability, cost, environmental and manufacturing requirementsReview electrical BOM's and schematics to drive cost reduction, improve reliability and optimize supply optionsEvaluate all process change notices (PCN's) from electronics parts suppliers and initiate appropriate internal actionsProactively manage component EOL and successful transition to qualified replacement candidatesQualifications:A BS degree in Electrical Engineering with 8+ years' experience as an Electrical Component EngineerwithSupplier management experienceORMaster's degree with 5+ years of experience ORDoctoral degree with 3+ years' experience.The subject matter expert on electrical componentsStrong negotiating and relationship building skillsCapable of driving in depth discussions on various technologies and trends in the industryExperience & understandingofRack and Cabinet Assemblies,Cables, Cable design and Cable products,Connectivity,Board components,Sensors&Electromechanicalcomponents required.Familiarity with GMP, ISO, and FDA rules and regulatory requirements for medical device industry.Extensive knowledge in GD&T and metrology & Experience in statistical analysisWorking experience with creating drawings, BOMs, product specifications, and engineering drawings.Proficiency with SolidWorks,MiniTab, and Microsoft Office applications.A strong understanding and ability with PLM softwareAbility to prioritize and handle multiple, concurrent projects.Excellent verbal and written communication skills, Anticipative and forward thinkingTeam attitude; eager to cooperate with others with exceptional interpersonal communication skillsExperience in a start-up environment strongly preferredA background in the Automotive, Consumer Electronics, or Medical Device industry preferred.Ability to travel up to 50% to vendor locations.Strong analytical skills, ability to leverage qualitative and quantitative data to resolve concerns and enhance decision making.A strong sense of integrity and dedication to ethical business practices

Keywords: Outset Medical, Inc., San Jose , Senior Component Engineer (Electrical), Other , san jose, California

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