Manager, Failure Investigation Engineering - Pleasanton, CA

About the company

Calyxo is a medical device company that develops the CVAC System, an irrigation-and-vacuum aspiration-based solution for minimally invasive kidney stone removal.

About this role

<div class="content-intro"><p>Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.</p> <p>Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.</p></div><p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Summary:</span><span data-ccp-parastyle="Normal (Web)">&nbsp;</span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}">&nbsp;</span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Th</span><span data-ccp-parastyle="Normal (Web)">e </span><span data-ccp-parastyle="Normal (Web)">Manager, </span><span data-ccp-parastyle="Normal (Web)">Failure Investigation </span><span data-ccp-parastyle="Normal (Web)">Engineering</span> <span data-ccp-parastyle="Normal (Web)">is r</span><span data-ccp-parastyle="Normal (Web)">esponsible for</span><span data-ccp-parastyle="Normal (Web)"> leading the team that investigates, analyzes, and resolves product complaints and adverse events. </span><span data-ccp-parastyle="Normal (Web)">This role ensures timely and compliant complaint handling while identifying trends and driving continuous improvement.</span><span data-ccp-parastyle="Normal (Web)"> The Manager works cross-functionally with Medical Affairs, Regulatory, Operations, R&amp;D, and Customer Service to support post-market surveillance activities and </span><span data-ccp-parastyle="Normal (Web)">maintain</span><span data-ccp-parastyle="Normal (Web)"> product safety and quality.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}">&nbsp;</span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">In This Role, You Will</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}">&nbsp;</span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="42" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Default" data-ccp-parastyle-defn="{"ObjectId":"272499da-5523-5969-b17c-4f82c0ce3910|1","ClassId":1073872969,"Properties":[469775450,"Default",201340122,"2",134233614,"true",469778129,"Default",335572020,"1",469777841,"Calibri",469777842,"Calibri",469777844,"Calibri",469769226,"Calibri",335551500,"0",268442635,"24",469777843,"Times New Roman"]}">Lead, mentor, and develop a team of investigators, engineers, and technicians by recruiting, onboarding, training, and managing performance through regular check-ins and annual reviews.</span></span><span data-ccp-props="{}">&nbsp;</span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="42" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Default">Set and manage individual and team goals aligned with departmental </span><span data-ccp-parastyle="Default">objectives</span><span data-ccp-parastyle="Default">.</span></span><span data-ccp-props="{}">&nbsp;</span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="42" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Default">Oversee the day-to-day operations of complaint investigations to ensure </span><span data-ccp-parastyle="Default">timely</span><span data-ccp-parastyle="Default"> closure and regulatory compliance.</span></span><span data-ccp-props="{}">&nbsp;</span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="42" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Default">Ensure </span><span data-ccp-parastyle="Default">investigation</span><span data-ccp-parastyle="Default"> documentation, procedures, and lab records are </span><span data-ccp-parastyle="Default">accurate</span><span data-ccp-parastyle="Default">, complete, and up to date per company policy.</span></span><span data-ccp-props="{}">&nbsp;</span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="42" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Default">Train team members on complaint investigation techniques, product-specific evaluations, and regulatory requirements.</span></span><span data-ccp-props="{}">&nbsp;</span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="42" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="