Calyxo is a medical device company that develops the CVAC System, an irrigation-and-vacuum aspiration-based solution for minimally invasive kidney stone removal.
<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)"> </span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">We are </span><span data-ccp-parastyle="Normal (Web)">seeking</span><span data-ccp-parastyle="Normal (Web)"> a skilled and detail-oriented Staff Quality Engineer to join our New Product Development (NPD) team. This role </span><span data-ccp-parastyle="Normal (Web)">is responsible for</span><span data-ccp-parastyle="Normal (Web)"> ensuring that our Class-II new products meet the highest quality standards throughout the development process, from concept to commercialization. The ideal candidate will have experience in the medical device industry and a strong understanding of quality engineering principles, design controls, project management, and regulatory requirements.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <p><span data-contrast="auto">This role will focus on ensuring that quality is embedded in the design, development, and manufacturing of new medical devices. The ideal candidate will have a strong background in quality engineering within the medical device industry, with experience supporting Class-II or Class-III product development lifecycle and software development, from concept through commercialization.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":240,"335559739":240}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">In</span><span data-ccp-parastyle="Normal (Web)"> This Role, You Will</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="33" 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="Normal (Web)">Ensure design controls for new product development and improvement project activities, including risk management, design V&V, product software validation, design reviews, tagging/tracing, non-product tools validation, test method validation, and design transfer are in compliance with </span><span data-ccp-parastyle="Normal (Web)">Calyxo</span><span data-ccp-parastyle="Normal (Web)"> Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and relevant global regulations.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="33" 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="Normal (Web)">Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="33" 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="Normal (Web)">Own and </span><span data-ccp-parastyle="Normal (Web)">maintain</span><span data-ccp-parastyle="Normal (Web)"> design control documentation in compliance with ISO 13485 and 21 CFR Part 820</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="33" 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="Normal (Web)">Collaborate with R&D, PMO, Regulatory Affairs, and Manufacturing to ensure robust design inputs, outputs, </span><span data-ccp-parastyle="Normal (Web)">traceability</span><span data-ccp-parastyle="Normal (Web)"> and quality considerations are integrated into all phases of the product development lifecycle.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769