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Rancho Cucamonga, California, United States · On-site
Senior
We are currently looking for an experienced technical specialist responsible for installing, maintaining, diagnosing, and repairing complex commercial systems, including HVAC units, refrigeration systems, and commercial …
Provide clinical insights for new product development through bench and animal model testing and evidence generation. Collaborate with cross-functional teams to refine procedural excellence and define customer requirements for medical devices.
Requirements
Requires a BS in Engineering with 5+ years of medical device experience, or an MS/PhD with 3+ years. Strong preference for candidates with experience in clinical engineering, animal studies, and direct interaction with physicians in surgical settings.
Full job description
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.
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.
Summary:
This position is responsible for providing clinical insights to support new product development and evidence generation through bench and animal model testing. The ideal candidate will also contribute to enhancing procedural excellence and refining current Calyxo commercial product offerings. Additionally, this role will assist in defining customer requirements and participate in physician evaluations during in-vitro bench testing, simulated-use studies, and in-vivo testing as needed for new product development.
In This Role, You Will:
Become an expert on the clinical application of Calyxo Inc’s products, kidney stone disease state and treatment, and the competitive landscape.
Develop in vitro and in vivo kidney models for evidence generation, technique optimization, training, and new product development. Research literature as needed to gather anatomical data necessary to develop appropriate in-vitro models.
Support the development and execution of test methods for evaluating and comparing the performance of devices (Company’s and competitive products) for marketing analysis and collateral, evidence generation, concept selection, design optimization, design verification & validation.
Contribute to the development of customer input requirements and support associated design validation testing plans, protocols, and test execution.
Support design and manage in-vitro, ex-vivo, and in-vivo product testing: study design, model design/development, and selection.
Collaborate with development teams to prepare and conduct physician evaluation sessions, including method/test sequence development, model design/selection, and data collection.
Ensure procedural excellence with Calyxo Inc products by combining engineering product knowledge, understanding of the complaints data, and in-field analysis of product performance.
Establish best practices for procedural techniques for field and customer training and to provide insights for new product development.
Evaluate and analyze procedural data including case videos, physician questionnaires, and complaints data.
Lead cross-functional alignment with Marketing, R&D and Professional Education to incorporate procedural best practices learnings into training materials.
Collaborate with Marketing and R&D to define clinical performance goals and perform risk assessments. Validate performance of the device relative to those goals.
Proctor cases evaluating advanced techniques. Create plans and systems to collect data from these initiatives.
Who You Will Report To:
Director, Clinical Development Engineering
Requirements:
BS in Engineering or related discipline with 5+ years related experience in the medical device industry; MS with 3+ years experience or PhD. Biomedical Engineering degree is a plus.
2+ years previous experience in medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc).
Strong background in hypothesis development and experimental testing, ideally within an academic or research setting
Prior experience interfacing directly with physicians in a surgical setting is strongly preferred.
Knowledge of and exposure to product testing and data collection required.
Experience in endourological procedures, techniques, devices, and pre-clinical testing is preferred.
Ability to travel 30%
Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities
Polished communicator and presenter with excellent listening, teaching, and program evaluation skills.
Effective interpersonal interactions, both within the commercial group and in accounts
Proficiency with PC-based office computers, including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook required
Ability to work independently
Valid driver's license
Compliance with relevant county, state, and Federal rules regarding vaccinations.
What We Offer:
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.
We also offer an attractive compensation package, which includes:
A competitive base salary range of $120,000 - $140,000 and variable incentive plan
Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid vacation
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Disclaimer:
At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:
Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of [email protected]. If you receive a request for information from any other domain, please contact us directly at [email protected]to verify the legitimacy of the communication.
We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.
Related keywords
Medical DevicesKidney Stone TreatmentUrologyEndourologyClinical DevelopmentBiomedical EngineeringIn-vitro ModelsIn-vivo ModelsEx-vivo TestingDesign OptimizationDesign VerificationDesign ValidationCustomer RequirementsProcedural ExcellenceRisk AssessmentClinical Performance Goals
Introducing CVAC System: A Revolution in Kidney Stone Care
Industry
Medical Equipment Manufacturing
Company size
201-500 employees
Founded
2016
Headquarters
Pleasanton, California
LinkedIn followers
19,494
Total funding
$165M
Calyxo, Inc. is an innovation-driven medical device company focused on improving care for patients with kidney stones, a common and painful condition that consumes vast amounts of healthcare resources today. Founded in 2016, Calyxo is led by executives and investors with a strong track record of commercializing paradigm-shifting solutions in the field of urology. Our team features some of the most talented, high-achieving and brightest minds in the medical device industry who are compelled by a desire to make a difference in kidney stone care. We are proud of our collaborative, diverse, fun and dynamic culture.
We drive our actions based on our core values which we call ‘F.I.T to WIN.’
Find Joy:
We celebrate wins and enjoy the journey!
Integrity:
We are truthful, honorable, and reliable.
Transparency:
We share what’s going on in our business. We are open, honest and have a clear communication across our organization.
Win as a Team:
We are earnest collaborators. We hold ourselves and each other accountable.
Offices: Willow Road, Pleasanton, California 94588, US
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