Job Title: Process Development Engineer I
Location : This position is based in our Campbell, California offices. This position is On-site and full-time
Why Imperative Care?
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing 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
This position will assist in product development projects defining, characterizing, optimizing and validating stable, robust and capable processes for neuro-interventional medical devices. They will assist in the improvement of internal equipment and processes. Responsibilities will include creative problem solving, critical thinking, application of engineering principles performing process characterization studies, collecting, and analyzing data, and documenting equipment/processes. 

• Work collaboratively but act autonomously to complete assigned tasks.
• Will assist in all stages of process design including definition, selection, characterization, optimization, and validation.
• Will participate in project teams to develop process windows, manufacturing control limits, and workmanship standards.
• Will participate in projects to define manufacturable product design specifications and visual standards.
• Will participate in the design, execution, test, and analysis of results from DOEs.
• Will assist in DMAIC projects to solve problems and find root cause.
• Will participate on equipment and process documentation.
• Will collaborate in cross functional teams to develop manufacturing workflows, effectivity monitoring control plans, lot history records.
• Will 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.
• Will 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.

What You’ll Bring

• 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
• 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, prioritise 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.
• Ability to work independently or in team setting and mentor/manage.
• Ability to travel – as required.

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply Today .
Salary Range: $84,000 – 89,000/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. 
 

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