Biomedical Device Development Engineer Jobs in Berkeley, CA

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