Principal Process Development Technician

Imperative Care•Campbell, CA

1d•$92,000 - $105,000•Onsite

About The Position

As a highly skilled technical specialist, the Principal Process Development Technician plays a critical role in the development, optimization, validation, and transfer of complex manufacturing processes for new and existing medical devices. This individual serves as the highest-level technician within Process Development and work in complex tasks requiring a high degree of creativity, initiative and experience to perform. Lead independently the development, refinement, and qualification of complex manufacturing processes supporting new product introduction and commercial process improvements. Design, build, and execute complex prototype and validation builds with minimal supervision, ensuring detailed documentation of all process inputs, outputs, and critical parameters. Serve as the technical specialist for advanced assembly methods (e.g., bonding, adhesives, soldering, fuse joining, thermal processes, precision fixturing). Lead and execute process characterization studies, including DOE support, capability assessments, and validation activities (IQ/OQ/PQ). Develop, optimize, and validate test methods and fixtures; perform and interpret statistical analyses of process and test data. Identify process risks and drive root cause investigations using structured problem-solving methodologies (e.g., DMAIC), implementing sustainable corrective actions. Lead equipment and fixture development activities, including definition, design input, build, debugging, qualification, maintenance strategies, and continuous improvement. Drive process documentation development and revision, including work instructions, protocols, reports, MPIs, LHRs, and change orders. Partner with engineers to translate product requirements into robust, scalable manufacturing processes suitable for transfer to production. Lead and support manufacturing transfer activities, including line setup, training development, and post-transfer process monitoring. Mentor, coach, and provide technical guidance to junior and senior technicians; establish best practices in build execution, documentation, and GMP compliance. Support vendor selection and evaluation for materials, tooling, and equipment; provide technical input for specifications and acceptance criteria. Support preclinical and clinical builds as required, ensuring compliance with protocols and regulatory standards. Act as a primary technical resource to Manufacturing during early production phases, troubleshooting complex issues on the line. Proactively identify and implement continuous improvement initiatives to improve yield, efficiency, repeatability, and cost.

Requirements

Minimum of 8 years of related experience in process development, manufacturing engineering support, or advanced medical device assembly; or equivalent combination of education and experience.
Extensive hands-on experience in medical device manufacturing processes and materials (polymers, metals, adhesives, chemicals).
Advanced knowledge of manufacturing and test equipment including hot boxes, bonding systems, soldering stations, fuse joining equipment, tensile testers, balloon testing, fatigue testing, and other regulated test platforms
Strong knowledge of GMP, GDP procedure and requirements with exposure to product manufacturing, testing, and data collection.
Demonstrated experience supporting process validations (IQ/OQ/PQ) and statistical analysis
Strong math skills with solid understanding of statistical concepts and data analysis
Proven ability to independently lead complex builds and technical projects from initiation through completion with minimal supervision
Strong written and verbal communication skills.

Responsibilities

Lead independently the development, refinement, and qualification of complex manufacturing processes supporting new product introduction and commercial process improvements.
Design, build, and execute complex prototype and validation builds with minimal supervision, ensuring detailed documentation of all process inputs, outputs, and critical parameters.
Serve as the technical specialist for advanced assembly methods (e.g., bonding, adhesives, soldering, fuse joining, thermal processes, precision fixturing).
Lead and execute process characterization studies, including DOE support, capability assessments, and validation activities (IQ/OQ/PQ).
Develop, optimize, and validate test methods and fixtures; perform and interpret statistical analyses of process and test data.
Identify process risks and drive root cause investigations using structured problem-solving methodologies (e.g., DMAIC), implementing sustainable corrective actions.
Lead equipment and fixture development activities, including definition, design input, build, debugging, qualification, maintenance strategies, and continuous improvement.
Drive process documentation development and revision, including work instructions, protocols, reports, MPIs, LHRs, and change orders.
Partner with engineers to translate product requirements into robust, scalable manufacturing processes suitable for transfer to production.
Lead and support manufacturing transfer activities, including line setup, training development, and post-transfer process monitoring.
Mentor, coach, and provide technical guidance to junior and senior technicians; establish best practices in build execution, documentation, and GMP compliance.
Support vendor selection and evaluation for materials, tooling, and equipment; provide technical input for specifications and acceptance criteria.
Support preclinical and clinical builds as required, ensuring compliance with protocols and regulatory standards.
Act as a primary technical resource to Manufacturing during early production phases, troubleshooting complex issues on the line.
Proactively identify and implement continuous improvement initiatives to improve yield, efficiency, repeatability, and cost.