Imperative Care is hiring a
Process Development Engineer I

Summary

The job is for a Process Development Engineer I at Imperative Care's Campbell, California office. The role involves assisting in product development projects, improving internal equipment and processes, and participating in various stages of process design and problem-solving activities. The company offers benefits such as stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Requirements

• Bachelor/Master ’s in Engineering or related discipline and less than 2 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
• Ability to work independently or in team setting and mentor/manage
• Ability to travel – as required

Responsibilities

• Assist in product development projects defining, characterizing, optimizing and validating stable, robust and capable processes for neuro-interventional medical devices
• Improve internal equipment and processes
• Participate in all stages of process design including definition, selection, characterization, optimization, and validation
• Participate in project teams to develop process windows, manufacturing control limits, and workmanship standards
• Participate in the design, execution, test, and analysis of results from DOEs
• Assist in DMAIC projects to solve problems and find root cause
• Participate on equipment and process documentation
• Collaborate in cross functional teams to develop manufacturing workflows, effectivity monitoring control plans, lot history records
• Participate in cross-functional teams to design, characterize, optimize, document, and control all manufacturing processes through the definition and measurement of critical process parameters (CPP) which impact critical quality attributes (CQA) of the product
• Employ analytical techniques and apply engineering principles to collect and analyze data in order to understand the impact and interaction of materials and processes on process and product outputs

Preferred Qualifications

• Able to perform computer modelling simulations on material, process & properties a plus
• Experience in pilot/production line set-up, validation in a controlled environment
• Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP
• Knowledge or experience in FDA Design Control procedures and DFSS/DFM tools a plus
• Excellent communications skills (both written and verbal)
• Strong critical thinking – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritize and provide creative, effective and practical solutions
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards
• Familiar with GMP, GDP procedures and requirements

Benefits

• Stock options
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program