Calyxo, Inc. · 5 hours ago
Senior Process Development Engineer - Pleasanton, CA
Pleasanton, CA
Full-time
Onsite
Senior Level, Lead/Staff
$145K/yr - $160K/yr
8+ years expCalyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The Senior Process Development Engineer will play a key part in product development by creating and optimizing manufacturing processes for new instruments, partnering with R&D, Quality, and other cross-functional groups.
Health CareMedicalMedical DeviceWellness
Responsibilities
Initiate, own, and complete technical projects resulting in new/improved processes for Calyxo products
Effectively communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines
Work closely with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability
Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety
Provide sustaining production line support, including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries
Train and support production personnel during transition of new products/processes to production, both locally and at international contract manufacturer
Generate and modify high-quality manufacturing process documentation and ensure that processes and documentation follow established policies and procedures
Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement
Assist in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment
Generate and modify component/assembly/equipment drawings using SolidWorks
Write and execute process and equipment validations (IQ/OQ/PQ)
Ensure product quality and support regulatory compliance
Qualification
Required
BS in Engineering or a combination of relevant education and experience
Minimum of 8 years of experience supporting medical device manufacturing
Experience with catheter manufacturing processes desired
Work location: Pleasanton, CA
Travel: 10%
Full time employment
Experience in leading highly technical projects in a cross functional environment
Experience working in a structured design process such as ISO9000 or FDA QSR and knowledge of regulatory approval process and requirements
Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001 and EN46001
Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks
Compliance with relevant county, state, and Federal rules regarding vaccinations
Benefits
Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid vacation
Company
Calyxo, Inc.
Calyxo, Inc.
201-500 employees
H1B Sponsorship
Calyxo, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$125.44MKey Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M
Leadership Team
Joseph Catanese
President & CEO
Doug Hughes
Chief Financial Officer
Recent News
2025-12-18
2025-10-21
Medical Product Outsourcing
2025-09-13
Company data provided by crunchbase