Manager, Systems and Test Engineering - Pleasanton, CA
Manager, Systems and Test Engineering - Pleasanton, CA
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$ 170000 - 195000
1 Vacancy
Job Description
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:
Were looking for aManager of Systems and Test Engineeringto lead the development of our next-generation endoscopic platforms. This is a hands-on leadership role where youll guide a multidisciplinary team through system architecture integration and verification of complex medical devices that combine imaging fluidics sensors and control systems. Youll play a critical role in ensuring our devices meet the highest standards of performance safety and regulatory compliance while helping shape the future of minimally invasive urology. This is an in-office position in Pleasanton CA.
In This Role You Will:
- Lead and Inspire:Manage and mentor a team of systems and test engineers working on advanced endoscopic technologies.
- Architect the Future:Oversee system-level design requirements engineering interface definition and risk management throughout the product lifecycle.
- Own the Test Strategy:Develop and execute robust system-level verification plans aligned with FDA and ISO standards.
- Build Smart Tools:Lead test method development including automated test equipment and simulated use protocols for both system and subsystem testing.
- Collaborate Cross-Functionally:Work closely with clinical software hardware vision systems and quality teams to ensure seamless system integration.
- Solve Complex Problems:Drive root cause analysis and resolution of system-level issues during development and testing.
- Ensure Traceability:Maintain clear traceability from requirements through design implementation and testing.
- Support Regulatory Success:Contribute to regulatory submissions and audits with high-quality technical documentation.
- Continuously Improve:Champion best practices in systems and test engineering processes tools and methodologies.
Who You Will Report To:
- See Organizational Chart
Requirements:
- Bachelors or Masters degree in Biomedical Electrical Mechanical or Systems Engineering.
- 8 years of experience in systems and/or test engineering with 3 years in a leadership role within the medical device industry.
- Proven track record with complex mechanical and electromechanical systemsideally in endoscopy or minimally invasive surgical devices.
- Deep knowledge of FDA QSR ISO 13485 IEC 60601 and ISO 14971.
- Experience with tools like JAMA DOORS Polarion TestRail and LabVIEW.
- Strong leadership communication and cross-functional collaboration skills.
- Experience with optical systems image processing or video-based medical devices.
- Familiarity with embedded systems testing.
- INCOSE CSEP certification or equivalent (preferred).
- Experience with Agile development and model-based systems engineering (MBSE).
- 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 of $170000 - $195000 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 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.
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.
Required Experience:
Manager
Employment Type
Full Time
