Director, Clinical Development Engineering

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 affect the attainment of project completion dates.
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
• Actively promote and support the company's Management Review process.
• Inform responsible personnel of concerns involving product quality.
• Perform job functions in a safe and effective manner.
• Manage engineering and/or technician staff on the Clinical Development Engineering Team

Who You Will Report To:

• VP, Marketing

Requirements:

• BS or advanced degree in a technically relevant field and 10 or more years' experience in medical device development (including experience in an entrepreneurial start-up environment)
• At least 6 years in a Clinical Development Engineering role.
• At least 3 years of previous supervisory experience
• Ability to work constructively with people at all levels of company, including senior management.
• Collaborate effectively with others to accomplish project goals.
• Multiple experiences in product development and execution through significant portions of the product development cycle
• Developed products under design control per ISO 13485 quality or comparable quality system.
• Prior experience in growing, nurturing, and leading an experienced engineering or technical team
• Experience and involvement with regulatory filings
• Solid knowledge and interpretation of applicable regulations, guidelines and policy statements (QSR, MDD, and ISO)
• Excellent written and oral communication skills; technical writing capabilities are a must.
• A proven decision maker, hands-on and action-oriented style must be evident.
• Proven ability to manage a team of professionals and prioritize multiple projects independently.
• Comfortable working with cadaver and animal models for device related testing and evaluation.

Work Environment:

• Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials
• Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
• Work includes potential exposure to chemicals.

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 a compensation plan as follows:

• Competitive base salary of $210,000.00 - $240,000.00
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

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.