Director, Clinical Development Engineering - Pleasanton, CA

Calyxo; Pleasanton (CA); On-site; USD 210,000 - 240,000; Full time

Job summary

An innovative medical device company seeks a Director of Clinical Development Engineering to lead a dynamic team focused on advancing kidney stone treatment. This pivotal role involves integrating clinical insights into product development, overseeing preclinical research, and collaborating with multidisciplinary teams. The ideal candidate will have extensive experience in medical device development, strong leadership skills, and a passion for improving patient outcomes. Join a forward-thinking organization that values diversity and fosters a culture of growth and innovation, offering a competitive salary and comprehensive benefits.

Benefits

Stock Options

401(k)

Healthcare

Paid Time Off

Qualifications

• 10+ years in medical device development, including entrepreneurial settings.
• Experience with design control systems and regulatory filings.

Responsibilities

• Lead product development, influencing decisions based on clinical insights.
• Manage preclinical studies and engage with clinicians for testing design.

Skills

Collaboration Skills

Leadership

Technical Writing

Decision-Making

Project Management

Education

Bachelor’s or higher degree in a relevant technical field

Tools

ISO 13485

Job description

Director, Clinical Development Engineering - Pleasanton, CA

Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. Founded in 2016, we focus on improving kidney stone treatment. Our team is led by experienced executives and investors with a successful track record in bringing innovative urology devices to market.

Are you ready to revolutionize kidney stone treatment? We seek high achievers eager to join a dynamic, diverse, and engaging team.

Position Overview:

This role leads the Clinical Development Engineering team, responsible for integrating clinical and procedural insights into product development, evidence generation, and procedural excellence. The individual will oversee pre-clinical research, design, and testing to advance product development in line with our Quality System and customer needs. Collaboration with marketing, product development, and clinical teams will shape product strategies and roadmaps. The role includes managing physician-driven evaluations, bench and simulated use testing, and in-vivo studies to define performance requirements and support marketing efforts.

Responsibilities:

1. Participate in product development leadership, influencing decisions on product pipelines based on clinical and customer insights.
2. Lead the team managing key aspects of product development, including customer requirements, design validation, anatomical expertise, and study coordination.
3. Develop and validate anatomical challenge models and oversee all preclinical testing activities.
4. Engage with clinicians and study centers for study planning, testing design, and product integration.
5. Drive product assessments to support development, validation, and marketing evidence.
6. Plan and execute preclinical studies, including bench tests, animal studies, and model development.
7. Collaborate with Clinical Affairs on evidence generation, publications, and abstracts.
8. Establish best practices for procedural techniques, combining engineering insights and field data.
9. Manage departmental budget and testing capabilities, promoting high standards.
10. Coordinate external stakeholder engagements and maintain testing excellence.
11. Ensure compliance with design control and quality standards during testing.
12. Work with multidisciplinary teams across R&D, regulatory, clinical, and other functions.
13. Lead team meetings, manage recruitment, and oversee performance management.
14. Promote the Quality Management System and ensure training on applicable procedures.
15. Support management review processes and address product quality concerns.
16. Perform these functions safely and effectively, managing staff as needed.

Reporting Line:

• Reports to the VP, Marketing

Minimum Requirements:

1. Bachelor’s or higher degree in a relevant technical field; 10+ years in medical device development, including entrepreneurial settings.
2. At least 6 years in a Clinical Development Engineering role.
3. Minimum 3 years of supervisory experience.
4. Strong collaboration skills and ability to work with all organizational levels.
5. Extensive product development experience across the product lifecycle.
6. Experience with design control systems like ISO 13485.
7. Proven leadership in managing engineering teams.
8. Involvement in regulatory filings.
9. Deep understanding of relevant regulations (QSR, MDD, ISO).
10. Excellent communication and technical writing skills.
11. Decision-making, hands-on, and action-oriented approach.
12. Ability to manage multiple projects independently.
13. Comfort working with cadaver and animal models.
14. Awareness of potential exposure to biological, chemical, or radiation hazards.

What We Offer:

Join Calyxo's talented team in a diverse environment that fosters growth, learning, and innovation. We offer a competitive salary ($210,000–$240,000), stock options, and comprehensive benefits including 401(k), healthcare, and paid time off. We value diversity and are committed to an inclusive workplace, welcoming applicants regardless of race, gender, or background. Legal work authorization in the U.S. is required.