Clinical Development Engineer Pleasanton, CA

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 Incs 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 (Companys 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 drivers 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 $120000 - $140000 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 onlyvalued but alsoprioritized. 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 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. If you receive a request for information from any other domain please contact us directly at 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.