Description

Title: Principal Process Development Technician Location: This position is full time and on-site in Campbell, CA Why Imperative Care? Do you want to make a real impact on patients? Imperative Care is changing the way stroke and vascular diseases are treated. As part of our team, you’d be supporting breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do What You’ll Do 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.<ul><li style="margin-right:49px;margin-left:8px;">Lead independently the development, refinement, and qualification of complex manufacturing processes supporting new product introduction and commercial process improvements.</li><li style="margin-right:49px;margin-left:8px;">Design, build, and execute complex prototype and validation builds with minimal supervision, ensuring detailed documentation of all process inputs, outputs, and critical parameters.</li><li style="margin-right:49px;margin-left:8px;">Serve as the technical specialist for advanced assembly methods (e.g., bonding, adhesives, soldering, fuse joining, thermal processes, precision fixturing).</li><li style="margin-right:49px;margin-left:8px;">Lead and execute process characterization studies, including DOE support, capability assessments, and validation activities (IQ/OQ/PQ).</li><li style="margin-right:49px;margin-left:8px;">Develop, optimize, and validate test methods and fixtures; perform and interpret statistical analyses of process and test data.</li><li style="margin-right:49px;margin-left:8px;">Identify process risks and drive root cause investigations using structured problem-solving methodologies (e.g., DMAIC), implementing sustainable corrective actions.</li><li style="margin-right:49px;margin-left:8px;">Lead equipment and fixture development activities, including definition, design input, build, debugging, qualification, maintenance strategies, and continuous improvement.</li><li style="margin-right:49px;margin-left:8px;">Drive process documentation development and revision, including work instructions, protocols, reports, MPIs, LHRs, and change orders.</li><li style="margin-right:49px;margin-left:8px;">Partner with engineers to translate product requirements into robust, scalable manufacturing processes suitable for transfer to production.</li><li style="margin-right:49px;margin-left:8px;">Lead and support manufacturing transfer activities, including line setup, training development, and post-transfer process monitoring.</li><li style="margin-right:49px;margin-left:8px;">Mentor, coach, and provide technical guidance to junior and senior technicians; establish best practices in build execution, documentation, and GMP compliance.</li><li style="margin-right:49px;margin-left:8px;">Support vendor selection and evaluation for materials, tooling, and equipment; provide technical input for specifications and acceptance criteria.</li><li style="margin-right:49px;margin-left:8px;">Support preclinical and clinical builds as required, ensuring compliance with protocols and regulatory standards.</li><li style="margin-right:49px;margin-left:8px;">Act as a primary technical resource to Manufacturing during early production phases, troubleshooting complex issues on the line.</li><li style="margin-right:49px;margin-left:8px;">Proactively identify and implement continuous improvement initiatives to improve yield, efficiency, repeatability, and cost.</li></ul> What You’ll Bring<ul style="margin-bottom:8px;"><li style="margin-left:8px;">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. </li><li style="margin-left:8px;">Extensive hands-on experience in medical device manufacturing processes and materials (polymers, metals, adhesives, chemicals). </li><li style="margin-left:8px;">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 </li><li style="margin-left:8px;">Strong knowledge of GMP, GDP procedure and requirements with exposure to product manufacturing, testing, and data collection. </li><li style="margin-left:8px;">Demonstrated experience supporting process validations (IQ/OQ/PQ) and statistical analysis </li><li style="margin-left:8px;">Strong math skills with solid understanding of statistical concepts and data analysis </li><li style="margin-left:8px;">Proven ability to independently lead complex builds and technical projects from initiation through completion with minimal supervision </li><li style="margin-top:8px;margin-bottom:8px;">Strong written and verbal communication skills. </li></ul>Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program. Salary Range: $92,000 – 105,000 annually Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer Join Us! <a href="https://imperativecare.com/careers/" style="color:#0000FF;text-decoration:underline;">Imperative Care</a>  The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care. Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.