Director, Clinical Development Engineering - 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.

Position Overview:

This position is responsible for leading the Clinical Development Engineering function, including a team of direct reports, which will be responsible for bringing clinical and procedural insights to New Product Development, Evidence Generation and Procedural Excellence initiatives. This individual will oversee all pre-clinical related research, design and testing to further the design and development of products in accordance with the company’s Quality System and customer requirements. This individual will support the marketing, product development, and clinical affairs leadership teams in shaping product development and roadmap strategy against customer needs and clinical performance requirements. This role will drive all aspects of physician-driven product evaluations, in-vitro bench and simulated use testing and in-vivo studies to define customer and clinical performance requirements, guide product development, and create engineering-driven marketing collateral, in partnership with Marketing.

Responsibilities:

• Key member of the product development leadership team, contributing to decisions on product development and pipeline as it relates to clinical performance and customer needs
• Lead the team responsible for the following critical aspects of product development:
• Co-ownership of customer input requirements, working closely with Product Management to identify unmet customer needs and translate those needs into clear, measurable, and testable requirements.
• Ownership of all aspects of design validation testing
• Understand how our product(s) will be used clinically, be the in-house expert on relevant anatomy, and intimately knowledgeable of current and emerging treatments and standards of care. Utilize said expertise for both product development & definition and internal education and development of internal teams
• Own all aspects of anatomical challenge model development and validation
• Interface directly with clinician customers, study centers, and advisors to establish and coordinate study schedules, to seek input into simulated use/in-vitro testing study design, product design, user interface, and possible integration of product with other medical systems or products.
• Leading product assessment activities (inclusive of requirements, test methods, and equipment) to support design decisions, trade-offs & risks, and competitive comparison for development, V&V and marketing evidence purposes
• Establish and execute detailed plans to support internal development projects with preclinical testing including bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
• Partner with Clinical Affairs to plan and execute preclinical studies to support evidence generation and drive abstracts and publications
• Establish best practices for procedural techniques for field and customer training by combining engineering product knowledge, understanding of the complaints data, and in-field analysis of product performance.
• Develop and maintain budget for pre-clinical department to support projects and to continually develop and improve internal testing capabilities
• Facilitate external stakeholder (e.g. physicians, investors, etc) engagements for product evaluation and demonstration purposes in partnership with cross-functional partners (e.g. marketing, project teams, senior management) Continually research, seek new information to establish and maintain high quality pre-clinical testing capabilities.
• Support project teams to ensure pre-clinical testing of new products are conducted within the design control and quality system.
• Work directly with multi-disciplinary product team comprised of R&D, regulatory, clinical, quality, manufacturing, marketing, sales, finance, and business development personnel.
• Plan and lead team regular meetings to facilitate communication and decision making.
• Manage recruitment, hiring, training and performance management of personnel toward productively achieving department goals.
• Provide regular feedback to management regarding project status, as well as other critical issues which af